Effects of SSMC With and Without Myofascial Release in Patients With Sciatica

NCT06696898 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0238
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Sciatica involves a radiating pain along the sciatic nerve, extending from the lower back through the hips and buttocks to each leg. Typically resulting from a herniated disk or spinal stenosis, this condition causes nerve compression that leads to pain, inflammation, and often numbness in the affected leg. Studies have shown that sensorimotor training with myofascial release can be effective in improving pain, lumbar range of motion and functional disability. The aim of this study is to evaluate the effects of Sensorimotor control training with and without myofascial releases on Pain, Lumbar range of motion and functional disability due to sciatica. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive somatosensory control training with Routine Physical Therapy for 45 minutes with short resting interval for Group B will receive Somatosensory training with myofascial release technique for 45min. Each group will receive treatment sessions of 3 days per week for 12 weeks.

Conditions

Sciatica Pain; Sciatica

Keywords

Sensorimotor Training; PNF Exercises; Functional Disability

Outcome Measures

Primary Outcomes (3)

• Oswestry Disability Index (ODI) (For functional disability)

  There are Total 10 Questions and each question, there is a possible 5 points: 0 for the first answer, 1 for the second answer, etc. Add up the total for the 10 questions and rate them on the scale at right. The ODI has good internal consistency (Cronbach α .86) and test-retest reliability (0.84). The scoring Interpretations of Oswestry Disability Index is 0% to 20%: minimal disability, 21-40% moderate disability, 41-60% severe Disability, 61-80% crippled and 81-100% are bed bound or exaggerating their symptoms.

  4th week

• Visual Analog Scale (For Pain)

  The VAS is a horizontal or vertical line, usually 10 centimeters (100 mm) in length. The ends are defined as the extreme limits of pain (e.g., "no pain" to "worst pain imaginable"). The participant is asked to mark on the line the point that represents their perception of their current pain level. A score 0mm No Pain, 30mm Mild Pain, 50mm Moderate Pain, 70mm severe Pain and 100mm Worst Pain imaginable

  1st day

• Modified Schober Test:(For Lumbar range of motion)

  In this Ask the participant to stand upright with feet together and mark a point 10 cm below and 5 cm above the L5 spinous process (the dimples of Venus and 10 cm caudally) and calculated by Subtract the baseline measurement (S1) from the flexion measurement (S2) to calculate the range of lumbar spine flexion. The difference between S1 and S2 represents the lumbar spine flexion range in centimeters.

  4th week

Study Arms (2)

Somatosensory Motor Control & Myofascial Release

EXPERIMENTAL

A series of proprioceptive and neuromuscular control exercises targeting lumbar stability and pain reduction.Somatosensory Motor Control \& Myofascial Release Procedure.MFR is Manual therapy technique that focused on releasing fascial restrictions to improve lumbar mobility and decrease pain.

Procedure: Somatosensory Motor Control Exercises; Procedure: Myofascial Release Technique

Sensorimotor training

ACTIVE COMPARATOR

Somatosensory motor control are Structured exercises aimed at enhancing proprioception and motor control to reduce pain and improve function in sciatica patients.

Procedure: Sensorymotor training

Interventions

Somatosensory Motor Control Exercises PROCEDURE

The Somatosensory motor control training protocol assembled into three components, 1) PNF exercises (Each patient alternately contracted trunk extensors and flexors isometrically for 10 seconds against maximum resistance while seated, then contracted trunk agonists alternately in a concentric and eccentric manner against manual resistance without relaxing, then moved his or her trunk in a twisting and diagonal orientation against maximum resistance), 2) Somatosensory exercises in which a wobbling board was used and six types of exercises were performed including hallowing, one lower limb elevation, opposite upper and lower limb elevation from a four-limb supported position (quadruped), abdominal reinforcement, maintaining a bridging posture, and one lower limb elevation from the bridging posture, and 3) finally Vestibular training which involved exercises to improve gaze focus, exercises for enhancing eye movements.

Somatosensory Motor Control & Myofascial Release

Myofascial Release Technique PROCEDURE

Manual therapy technique that applies sustained pressure to myofascial tissues around the lumbar spine and pelvis to release tension and improve mobility.Myofascial Release Technique MFR is given with the ulnar border from proximal to distal direction with a light gentle pressure over the hamstring muscle until the slack in the skin is loosened. (2) Every strike is to be held for 30 seconds, 5 repetitions per session

Somatosensory Motor Control & Myofascial Release

Sensorymotor training PROCEDURE

The Somatosensory motor control training protocol assembled into three components, 1) PNF exercises (Each patient alternately contracted trunk extensors and flexors isometrically for 10 seconds against maximum resistance while seated, then contracted trunk agonists alternately in a concentric and eccentric manner against manual resistance without relaxing, then moved his or her trunk in a twisting and diagonal orientation against maximum resistance), 2) Somatosensory exercises in which a wobbling board was used and six types of exercises were performed including hallowing, one lower limb elevation, opposite upper and lower limb elevation from a four-limb supported position (quadruped), abdominal reinforcement, maintaining a bridging posture, and one lower limb elevation from the bridging posture, and 3) finally Vestibular training which involved exercises to improve gaze focus, exercises for enhancing eye movements.

Sensorimotor training

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient Diagnosed with sciatica (confirmed by clinical examination and imaging)
• Patient with Unilateral sciatica pain
• Patient Experiencing symptoms for at least 3 months
• Pain (VAS) score ≥ 5) in the lumbar and/or lower extremity region in patients.
• The disability with a score of at least 20% by the Oswestry Disability Index (
• Stable patient , no recent changes in treatment regimen for sciatica within the past 4 weeks

You may not qualify if:

• Patients with Lumbar spine surgery history within the past 6 months (11)
• Patients who have been Another clinical trial participant within the past 3 months (1).
• Patients with Physical therapy interventions contraindicated like in Severe cardiovascular disease and Uncontrolled hypertension Acute disc herniation requiring urgent surgical intervention (10).
• Patients with Significant comorbidities like malignancy, spinal infection and Severe osteoporosis affecting spine stability (14).
• Inability in patients to communicate effectively in Urdu or English, hindering comprehension of study instructions and assessments.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Well Versed Physio clinic

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (14)

• Ostelo RW. Physiotherapy management of sciatica. J Physiother. 2020 Apr;66(2):83-88. doi: 10.1016/j.jphys.2020.03.005. Epub 2020 Apr 11. No abstract available.

  PMID: 32291226 BACKGROUND

• Fairag M, Kurdi R, Alkathiry A, Alghamdi N, Alshehri R, Alturkistany FO, Almutairi A, Mansory M, Alhamed M, Alzahrani A, Alhazmi A. Risk Factors, Prevention, and Primary and Secondary Management of Sciatica: An Updated Overview. Cureus. 2022 Nov 12;14(11):e31405. doi: 10.7759/cureus.31405. eCollection 2022 Nov.

  PMID: 36514653 BACKGROUND

• Bello B, Danazumi MS, Kaka B. Comparative Effectiveness of 2 Manual Therapy Techniques in the Management of Lumbar Radiculopathy: A Randomized Clinical Trial. J Chiropr Med. 2019 Dec;18(4):253-260. doi: 10.1016/j.jcm.2019.10.006. Epub 2020 Sep 3.

  PMID: 32952470 BACKGROUND

• Brumagne S, Diers M, Danneels L, Moseley GL, Hodges PW. Neuroplasticity of Sensorimotor Control in Low Back Pain. J Orthop Sports Phys Ther. 2019 Jun;49(6):402-414. doi: 10.2519/jospt.2019.8489.

  PMID: 31151373 BACKGROUND

• Khan T, Rizvi MR, Sharma A, Ahmad F, Hasan S, Uddin S, Sidiq M, Ammari A, Iqbal A, Alghadir AH. Assessing muscle energy technique and foam roller self-myofascial release for low back pain management in two-wheeler riders. Sci Rep. 2024 May 27;14(1):12144. doi: 10.1038/s41598-024-62881-8.

  PMID: 38802553 BACKGROUND

• Ozsoy G, Ilcin N, Ozsoy I, Gurpinar B, Buyukturan O, Buyukturan B, Kararti C, Sas S. The Effects Of Myofascial Release Technique Combined With Core Stabilization Exercise In Elderly With Non-Specific Low Back Pain: A Randomized Controlled, Single-Blind Study. Clin Interv Aging. 2019 Oct 9;14:1729-1740. doi: 10.2147/CIA.S223905. eCollection 2019.

  PMID: 31631992 BACKGROUND

• Ozog P, Weber-Rajek M, Radziminska A, Goch A. Analysis of Postural Stability Following the Application of Myofascial Release Techniques for Low Back Pain-A Randomized-Controlled Trial. Int J Environ Res Public Health. 2023 Jan 26;20(3):2198. doi: 10.3390/ijerph20032198.

  PMID: 36767565 BACKGROUND

• van Dieen JH, Reeves NP, Kawchuk G, van Dillen LR, Hodges PW. Motor Control Changes in Low Back Pain: Divergence in Presentations and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):370-379. doi: 10.2519/jospt.2019.7917. Epub 2018 Jun 12.

  PMID: 29895230 BACKGROUND

• Goossens N, Janssens L, Brumagne S. Changes in the Organization of the Secondary Somatosensory Cortex While Processing Lumbar Proprioception and the Relationship With Sensorimotor Control in Low Back Pain. Clin J Pain. 2019 May;35(5):394-406. doi: 10.1097/AJP.0000000000000692.

  PMID: 30730445 BACKGROUND

• Marchand F, Laudner K, Delank KS, Schwesig R, Steinmetz A. Effects of Sensorimotor Training on Transversus Abdominis Activation in Chronic Low Back Pain Patients. J Pers Med. 2023 May 11;13(5):817. doi: 10.3390/jpm13050817.

  PMID: 37240987 BACKGROUND

• Amjad F, Mohseni-Bandpei MA, Gilani SA, Ahmad A, Waqas M, Hanif A. Urdu version of Oswestry disability index; a reliability and validity study. BMC Musculoskelet Disord. 2021 Mar 29;22(1):311. doi: 10.1186/s12891-021-04173-0.

  PMID: 33781267 BACKGROUND

• Jenks A, Hoekstra T, van Tulder M, Ostelo RW, Rubinstein SM, Chiarotto A. Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale: Which Has Superior Measurement Properties in Older Adults With Low Back Pain? J Orthop Sports Phys Ther. 2022 Jul;52(7):457-469. doi: 10.2519/jospt.2022.10802. Epub 2022 May 18.

  PMID: 35584027 BACKGROUND

• Xu HR, Zhang YH, Zheng YL. The effect and mechanism of motor control exercise on low back pain: a narrative review. EFORT Open Rev. 2023 Jul 3;8(7):581-591. doi: 10.1530/EOR-23-0057.

  PMID: 37395680 BACKGROUND

• Tousignant M, Poulin L, Marchand S, Viau A, Place C. The Modified-Modified Schober Test for range of motion assessment of lumbar flexion in patients with low back pain: a study of criterion validity, intra- and inter-rater reliability and minimum metrically detectable change. Disabil Rehabil. 2005 May 20;27(10):553-9. doi: 10.1080/09638280400018411.

  PMID: 16019864 BACKGROUND

MeSH Terms

Conditions

Sciatica

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Aruba Saeed, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: September 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: May 30, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)