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To investigate the effectiveness of radial extracorporeal shock wave therapy (rESWT) on pain, lumbar range of motion (ROM) and F-wave minimal latency and F-chronodispersion in patients with post laminectomy epidural fibrosis.
Methods
Sixty patients complaining of low back pain and sciatica secondary to lumbar post laminectomy epidural fibrosis were allocated to one of the two equal groups (study and control groups). Pain intensity, lumbar ROM, and F-wave latency and F-chronodispersion were assessed pre- and posttreatment using visual analogue scale (VAS), Back ROM II device, and Neuro-MEP-Micro electromyography device, respectively.
Results
Posttreatment mean values showed statistically significant decrease in VAS mean scores in both groups, with more significant decrease posttreatment in favor of the study group. There was statistically significant increase in all lumbar ROM mean scores and statistically significant decrease in F-minimal latency and F-chronodispersion for both peroneal and tibial nerves in the study group only posttreatment. Also, the results showed that significant positive moderate correlation between VAS scores and F-chronodispersion for peroneal nerve, strong negative correlation between right side bending scores and F-wave minimal latency for peroneal nerve and moderate negative correlation between left side bending scores and F-wave minimal latency for peroneal nerve after treatment.
Conclusion
It was concluded that rESWT is a new and convenient modality, that would be beneficial if added to the conventional physical therapy protocols in managing patients with lumbar post-laminectomy epidural fibrosis.
Lumbar laminectomy is the most common surgical procedure used in treating symptoms of lumbar radiculopathy caused by disc herniation. It is characterized by decompression of the neural structures passing through the intervertebral foramen and the spinal canal [1-3]. Although lumbar laminectomy improved patient’s symptoms after surgery, recent systematic reviews reported that the improvement was not at the satisfactory level either after surgery or at 5 years follow up [4]. One of the most common complications after lumbar laminectomy is epidural fibrosis developed as a result of abnormal excessive healing tissues in the area of excision. It was found that the rate of fibroblasts’ proliferation is the main factor responsible for developing epidural fibrosis, as it is transformed into myofibroblasts causing adhesions into the dura mater and nerve root leading to recurrent back and leg pain [1,5].
Epidural fibrosis constitutes 24% of all failed back surgery syndrome (FBSS) cases or post laminectomy syndrome (PLS), and is thus claimed as one of the major causes of FBSS with high incidence per year. Being resistant to treatment, chronic pain caused by epidural fibrosis could affect social function, work efficiency and activities of daily living. It may cause depression, anxiety, disability and consequently deterioration in patient’s quality of life Therefore, it is important to find treatment options for decreasing pain in these patients [6]. Recently, the number of researches studied the mechanism and management of epidural fibrosis after lumbar surgery has been increased [1]. As epidural fibrosis is a part of PLS, treatment should target the source of pain, thus both conservative approaches as physiotherapy and pain medications and invasive approaches such as lumbar steroid injections, percutaneous endoscopic adhesiolysis, and re-operation for managing PLS could be used [7]. Yet, as surgical options have showed high morbidity and low success rate, they should not be prioritized to conservative approaches in treatment unless in cases of impaired bowel and bladder function, progressive weakness or interactable pain [3]. Systematic reviews of studies investigating pharmaceutical management using opioids and/or non-surgical management of PLS have shown that there was a non-significant improvement either in pain or patient’s function, thus eventually resulting in re-operation [8,9]. New non-invasive and safe treatment method, including radial extracorporeal shock wave therapy (rESWT) have recently been proposed, studied and implemented in clinical practice [1,10].
rESWT is now widely used in many musculoskeletal conditions such as frozen shoulder, plantar fasciitis, lateral epicondylitis, tendon calcification, hypertrophic wounds, scar tissues [10,11]. Also, rESWT showed an impact on in neuropathic pain caused by sciatica, post herpetic neuralgia and mild to moderate carpal tunnel syndrome [12,13]. It has been recently used as alternative treatment in case of low back pain (LBP) and sciatic neuralgia [14,15]. Previous studies showed that rESWT (low energy waves) has no adverse effects or complications, if the contra-indications are considered. Shock waves are acoustic pressure pulses, produced by electrohydraulic, electromagnetic and piezoelectric sources, can penetrate through tissues in a wave like manner [16]. The physiological mechanism through which it produces its effect would involve affecting cell activity through its regeneration and anti-inflammatory effect. The application of rESWT reduces inflammatory cytokines and increases collagen fibers, tendons and soft tissue flexibility and improves local blood flow. Thus, it has been recommended in cases of fibrosis and adhesions [17,18]. In an animal study, it was concluded that the rESWT reduces epidural fibrosis developed following intentional laminectomy in rats [1]. To the best of our knowledge, the effect of rESWT on epidural fibrosis secondary to lumbar laminectomy in humans has not been investigated in previous clinical study. So, the current study aimed to investigate the effect of rESWT on pain and limited lumbar range of motion (ROM) due to post-laminectomy epidural fibrosis.
METHODS
Research design
The current study employed pretest/posttest randomized controlled study design. The patients were referred from the Orthopedic Surgery and Neurosurgery Departments of Cairo University Hospital and General Hospital. The study was conducted from January 2023 to April 2024 in the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University. Before participation in the current study, every patient received an explanation of the aim and procedures of the study and signed a consent form prior to their enrollment. This study was approved by the Ethics Committee of the Faculty of Physical Therapy, Cairo University (approval number: P.T.REC/012/004382). The study was registered at the Clinical Trial Registry (NCT05887024).
A total of sixty-nine patients of both sexes with lumbar epidural fibrosis were assessed for recruitment eligibility in the current study. Four patients declined participation, and five patients did not fulfill the inclusion/exclusion criteria and hence were excluded. The selected patients were allocated by computerized block randomization. A diagram of patients’ retention and randomization throughout the study was shown in (Fig. 1). Patients were randomly assigned to either the study group (n=30) that received rESWT in addition to conventional physical therapy program in the form of transcutaneous electrical nerve stimulation (TENS), electric heating packs and McKenzie back exercises, or the control group (n=30) that received conventional physical therapy program only. Every patient was assessed before and after treatment.
All recruited patients should fulfill the inclusion criteria, which include: (1) patients had lumbar laminectomy surgery at the level L4–5, L5–S1; (2) six week to six month post operatively, as epidural fibrosis takes this duration to be matured [19]; (3) constant back pain or pain aggravated by movement; (4) restricted lumbar ROM; (5) tenderness at the site of incision; (6) epidural fibrosis confirmed by contrast magnetic resonance imaging (MRI); (7) age ranged from thirty to fifty years [20]; and (8) body mass index (BMI) less than 30 kg/m2. Patients having any of the following criteria were excluded from the current study: (1) past history of vertebral fracture; (2) spinal cord compression; (3) spinal tumor; (4) spondylolisthesis; (5) diabetic neuropathy; (6) pregnancy; and (7) vascular diseases [16,20].
Research procedure:
Pain intensity, lumbar ROM, and F-wave minimal latency and F-chronodispersion (Fc) of tibial and peroneal nerves were measured for all recruited patients before and after treatment using visual analogue scale (VAS) [20,21], the Back ROM II device (BROM II; Fabrication Enterprises), and Neuro-MEP-Micro electromyography device (Neurosoft Company), respectively. The BROM II is designed to measure the back flexion/extension ROM using the BROM F/E (flexion/extension) unit with an L-shaped arm inserted in the distal part of the unit to measure separation distance between T12 and S1 during movement. It, as well, measures the rotation and lateral flexion ROM using the BROM R/L (rotation/lateral flexion) unit, including it magnetic reference and belt [22]. Routine measurement for both F-wave minimal latency and Fc was applied using Neuro-MEP-Micro electromyography device. It was reported that F-wave study has a sensitivity of 70% in lumbosacral radiculopathy patients [23]. The study group received rESWT using the MEDISON MB3000 shockwave instrument (SN.2012.12), in addition to conventional physical therapy program in form of TENS: EME (Therapic 9400) [24], Electric heating pack [25], and McKenzie back exercises were used [20].
Procedures for data collection
After screening of eligible patients, demographic and anthropometric data in form of name, age, gender, height, weight, BMI and occupation were recorded. BMI was calculated for each participant. Patients were asked to mark a point on a 10 cm line (VAS) indicating their pain intensity in relation to zero end, and the score was calculated using a ruler measuring the distance between the patients mark and the zero point [26]. Assessment of lumbar ROM (flexion, extension, lateral flexion and rotation) was measured using BROM II device [24]. The procedures to obtain F-wave minimal latency and Fc were the same as procedures for routine motor conduction studies for peroneal and tibial nerves using distal stimulation except with that the cathode was placed proximally, the recording electrodes for peroneal nerve were placed at the extensor digitorum brevis muscles, active electrode (G1) at dorsal lateral foot on the muscle belly, reference electrode (G2) placed distally at the 5th metatarsal joint, stimulating electrode placed lateral to tibialis anterior tendon, with the cathode placed proximally, ground electrode placed between recording ant stimulating electrodes. The stimulating electrodes for tibial nerve placed at the abductor hallucis brevis, G1 positioned 1 cm proximal and 1 cm inferior to navicular prominence, G2 placed at the 1st metatarsal joint, stimulating electrode placed at above and posterior to medial malleolus. Ground electrode placed between stimulating and recording electrodes. To obtain F-wave minimal latency and Fc, ten supramaximal stimuli were applied [27]. Every patient in the study group received 10 sessions of rESWT, 2 sessions/week. The patients were requested to assume the prone lying position, and the radial shockwave applicator (probe) was applied on the incisional line of the surgery which is in line with the vertebral column (level L4–5 & L5–S1) using conducting gel (in the center of back in line with the spine). During session time, the probe is moved along the incisional line (linear movement & direct contact). The used parameters were; 5,000 pulses/10 Hz/3 bar. Penetration depth of rESWT is 3.0 to 3.5 cm in human tissues [28]. Energy flux density is 0.10–0.15 mJ/mm2. Low energy waves were used, which is safe for neural and muscular tissues and not causing any adverse effects. After each session the skin was checked for any undue changes like hyperemia, or allergy [16].
The conventional TENS was applied along the course of the sciatic nerve using four electrodes, which were placed as follows; on back region, lateral gluteal area, lateral popliteal fossa and posterior ankle joint [20], with the application parameters as follows; 120 Hz pulse frequency, 100 μs pulse duration and 20 minutes session duration. The amplitude was increased gradually till the patient starts to feel comfortable tingling sensations. Electric heating pad was applied on the incisional site for 20 minutes [29]. McKenzie back exercises were explained to all patients, which include a gradual progressive back exercises in the form of raising head and chest and back from prone lying position, bridging exercises, raising one arm and one opposite leg simultaneously from prone lying position, treatment duration was ten minutes [20].
Data analysis
The sample size for this study was calculated using the G*Power program 3.1.9 (G power program version 3.1). Sample size calculation based on F-tests (MANOVA: special effects and interactions), type I error (α)=0.05, power (1-β error probability)=0.90, effect size f2 (V)=0.2456983, and Pillai V=0.3944748, with a total sample size for 54 participants for 2 independent groups comparison for major variable outcomes (pain intensity level, lumbar ROM in flexion, extension, right and left lateral rotation, and right and left side bending, F-wave minimal latency and Fc of peroneal and tibial nerves). Considering a 10% drop out rate, the minimum sample size of the current study was determined to be 60 patients (30 patients per group). Demographic and anthropometric data were analyzed using descriptive statistics and expressed as mean and standard deviation. MANOVA was used to compare within and between groups effects on VAS, lumbar ROM (flexion, extension, lateral flexion and rotation, F-minimal latency and Fc for both peroneal and tibial nerves). Post-hoc tests using the Bonferroni correction were conducted for subsequent multiple comparisons. The level of significance for all statistical tests was kept at p˂0.05. Pearson’s correlation coefficient was performed to compute the relation and direction between VAS with Fc for peroneal nerve and between lumbar ROM with F-minimal latency for peroneal nerve.
RESULTS
Sixty patients with LBP and sciatica due to lumbar post-laminectomy epidural fibrosis from both genders, were recruited in the current study. The mean of patients’ age in the study group and control group were 43.03±5.07 and 44.23±3.55 years, respectively. Patients’ weight, height and BMI in the study group were 69.43±5.00 kg, 165.17±6.12 cm, and 25.47±2.22 kg/m2, respectively and 69.03±3.81 kg, 163.73±6.43 cm, and 25.82±2.24 kg/m2 in the control group, respectively. Patients demographic data showed no statistically significant difference between both groups. The study group included 16 male patients (53.3%) and 14 female patients (46.7%), while in control group, they were 14 male patients (46.7%) and 16 female patients (53.3%; Table 1).
Mixed ANOVA was conducted to investigate the effect of rESWT on main the variable outcomes (pain intensity level, and lumbar ROM). There was a significant interaction effect of groups and time (Wilks’ lambda value=0.163, η2=0.837, F-value=80.699, p=0.0001). Moreover, there was a significant of main effect of tested groups (Wilks’ lambda value=0.163, η2=0.837, F-value=80.842, p=0.0001). Also, there was a significant main effect of time (Wilks’ lambda value=0.073, η2=0.927, F-value=199.441, p=0.0001).
Pain intensity showed a statistically significant reduction of mean VAS scores of both groups posttreatment compared to pretreatment (p=0.0001). Pretreatment comparison between groups, showed non-significant difference between groups (p=0.226), while posttreatment scores showed a statistically significant decrease between groups in favor of the study group (p=0.0001; Table 2).
The results of this study regarding lumbar ROM showed there was no statistically significant difference in lumbar ROM in all directions posttreatment in control group, and a statistically significant increase in the posttreatment mean values of all lumbar ROM scores in all directions, in the study group (p=0.0001). Between groups comparison showed non-significant difference in pretreatment mean values of all lumbar ROM scores, and a statistically significant increase in all ROM scores between both groups posttreatment in favor of the study group (p=0.0001; Table 2).
F-wave minimal latency for both peroneal and tibial nerves results showed a significant decrease at posttreatment compared with pretreatment in study group only (p=0.0001). However, there was a non-significant difference at posttreatment compared with pretreatment in control group (p=0.701, p=0.498) for both peroneal and tibial nerves respectively. Between groups comparison showed a non-significant difference in pretreatment mean values (p=0.163, p=0.053) for peroneal and tibial nerves respectively, and a statistically significant decrease posttreatment between both groups in favor of the study group (p=0.0001) for both nerves. For Fc (peroneal and tibial) results showed a significant decrease at posttreatment compared with pretreatment in the study group only (p=0.0001) for both nerves. However, control group showed non-significant difference at posttreatment compared to pretreatment (p=0.445, p=0.277) for peroneal and tibial nerves, respectively. While there was a statistically significant decrease between both groups posttreatment in favor of the study group (p=0.0001) for both nerves (Table 3). The results of the correlational analyses between clinical and electrophysiological studies revealed that there was significant positive moderate correlation between VAS scores and Fc peroneal scores (r=0.37, p=0.044; Table 4). And strong negative correlation between right side bending and peroneal F-minimal latency (r=-0.50, p=0.005; Fig. 2). Moreover, a significant negative moderate correlation between left side bending and peroneal F-minimal latency (r=-0.42, p=0.019; Fig. 3).
DISCUSSION
Epidural fibrosis, the most common cause of PLS, develops following lumbar laminectomy due to excessive healing process [1,4]. Epidural fibrosis leads to recurrent or persistent back pain and leg pain due to compression on the nerve root or dura mater [30]. Paraspinal muscles dissection and bone resection is currently believed to produce migration of fibroblasts to the epidural space, and in conjunction with the differentiation of myofibroblasts, accumulation of fibronectin and the increase in extracellular components eventually causes the development of fibrosis. Additionally, TGF-1β secreted from fibroblasts increase the formation of fibrosis [1]. Therefore, this study was conducted to investigate the effect of rESWT on pain, lumbar ROM and electrophysiological parameters in patients with epidural fibrosis.
The results of the current study showed a significant reduction in pain intensity reflected as a decrease in the posttreatment VAS scores in both groups with more significant decrease in the study group.
Several mechanisms could explain the observed reduction in pain intensity in favor of the study group. The first one is that rESWT has an anti-inflammatory effect which could reduce peri-neural compression [13,31]. This explanation was supported by the findings of Haberal et al. [1], Kaya Şimşek et al. [10], Lee et al. [17], and Zhou and Yang [18] who found that rESWT application is effective in stimulating nitric oxide synthase and stimulating production of nitric oxide, which have anti-inflammatory effect in musculoskeletal disorders.
The second mechanism is that rESWT produces analgesic effect, that is possibly referred to improved local capillary blood circulation, that in turn reduces muscle tension and stiffness, which in turn alleviates pain. Also, rESWT can reduce the flow of excessive stimuli affecting nociceptors and stimulation of nerves which result in changes of free radicles around the cell, increasing cell permeability, inhibiting transmission of pain signals, increasing pain threshold and promoting cell angiogenesis through its piezoelectric, mechanical and cavitation effect [32]. This explanation was supported by a study of Hausdorf et al. [33] who stated that rESWT selectively destroys non-myelinated nerve fibers and reduces the level of substance P in the dorsal root ganglia that eventually reduces pain in musculoskeletal tissues.
The third mechanism is that rESWT has anti-fibrotic effect due to its role in reduction of TGF-1β, collagen and fibronectin levels, which play a crucial role in developing fibrotic tissues [1,10,17,18]. This explanation was supported by the findings of Zhao et al. [34] who induced a trophic wound model in rabbits and could thus conclude that low as well high energy rESWT reduced fibroblastic density which plays a crucial role in developing scar tissue. Also, Haberal et al. [1] investigated the effect of rESWT on post laminectomy epidural fibrosis on rats and concluded that rESWT application decreased fibrosis after laminectomy.
In the current study, control group showed significant reduction in pain intensity, which concur with the findings of Sharaf et al. [20], who concluded that conventional physical therapy program (TENS, hot packs and McKenzie exercises) has an effect on managing pain in PLS patients. The significant decrease of pain intensity in the control group posttreatment compared with pretreatment might be attributed to the role of TENS and hot packs in reducing pain through the activation of gate control theory [24]. Nevertheless, McKenzie exercises might reduce pain through two mechanisms. Firstly, increasing level of serotonin opioids which decreases pain [4,19]. Secondly, Back pain in patients with PLS might be also attributed to back muscle weakness due to incision. Weakness of superficial trunk muscles is one important risk factor for LBP [35] and strengthening of these muscles is often associated with significant reduction of chronic LBP. So, the second explanation might be attributed to the role of McKenzie exercises in improving back muscle strength. Abdi et al. [36] claimed back extension exercise to cause significant reduction of back pain after lumbar surgery, which support the findings of the current study.
In the current study the lumbar ROM showed a significant increase in lumbar ROM in all directions posttreatment compared to pretreatment in the study groups. The significant increase of all lumbar ROM in the study group might be attributed to significant reduction of pain in the study group. This explanation is based on the fact that back pain is the cause of limited lumbar ROM. Also, the significant increase in all lumbar ROM in the study group could be explained as an effect of anti-fibrotic effect produced by rESWT, which leads to breakdown of adhesions. This explanation was confirmed by El Naggar et al. [37] who emphasized the role of rESWT in reducing the fibrotic density, thus improving ROM.
F-wave is one of late responses which stimulate the motor peripheral nerve, the stimulus propagates up towards the alpha motor neuron of the anterior horn cells of the spinal cord and then pass distally in the efferent fibers towards the recorded muscle (extensor digitorum brevis or abductor hallucis longus). F-wave pass along fibers of the nerve root L5 or S1. So, any damage or lesion caused by compression on nerve root could be affect the F-wave parameters [38]. Regarding the results of F-wave minimal latency and Fc. There was a significant decrease at posttreatment compared to pretreatment in study group. The control group showed non-significant decrease either within or between groups.
The significant improvement in F-minimal latency and Fc might be attributed to decreases of compression on nerve root caused by epidural fibrosis. This explanation was supported by that rESWT can reduce the fibrotic density which could cause compression on nerve root, causes prolongation of either F-wave minimal latency and Fc [1]. This compression is caused by the migration of fibrous tissues to the dura and surrounding nerve roots, which is the main cause of recurrent radiculopathy [39].
The results regarding correlation between VAS and peroneal Fc showed a significant positive correlation between VAS and peroneal Fc. The correlation might be attributed to that prolongation of Fc is due to compression on nerve root caused by epidural fibrosis, which is in turn cause of pain after lumbar laminectomy [39]. Also, the negative correlation between lumbar ROM of side bending and peroneal F-wave minimal latency might be attributed to the impact and/or relation of lumbar side bending on the intervertebral foramen dimensions (width, height and area). The degree of change in the foraminal area is strongly correlated to spinal segmental motion [40]. As mentioned before the prolongation of F-minimal latency is due to proximal nerve compression which leads to proximal focal demyelination on nerve root [23].
Limitations
The study has some limitations, blinding of the physiotherapist that applying interventions (second author) was not possible. However, the author responsible for collecting data (second author) was blinded to group allocation. The surgeon who did the operation was not the same person, and this might affect treatment results. Future studies are recommended to be conducted on post laminectomy epidural fibrosis patients operated by same surgeon. It is recommended to conduct further studies to determine the long-term effect of rESWT on pain and lumbar ROM, measurement of fibrosis density posttreatment by contrast MRI. Lack of sham group in this study is one of the limitations, that could be recommended for future studies. As most of FBSS patients are over 50 years, it is recommended to apply study targeting this population.
CONFLICTS OF INTEREST
No potential conflict of interest relevant to this article was reported.
FUNDING INFORMATION
None.
AUTHOR CONTRIBUTION
Conceptualization: Rashad UM. Data curation: Abousenna MH, Rehab NI. Methodology: Abousenna MH. Project administration: Rashad UM, Rehab NI. Investigation: Elsamman AK. Supervision: Rashad UM, Elsamman AK, Rehab NI. Validation: Rashad UM. Visualization: Rashad UM. Writing – original draft: Abousenna MH. Writing – review & editing: Rashad UM, Rehab NI. Approval of final manuscript: all authors.
ACKNOWLEDGMENTS
The authors would like to thank the non-academic staff members of the College of Medicine, Cairo University for their role during the study.
Strong correlation (±0.50 to ±1), medium correlation (±0.30 to ±0.49), and small correlation (<±0.29).
VAS, visual analogue scale.
*Significant: (p<0.05).
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