Comparative Effects of SWT and Maitland LM in Mechanical LBP

NCT05404997 | Unknown

• 1 other identifier: REC/RCR&AHS/22/0127
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a common neuro-musculo-skeletal problem affecting 40% of world's population at some point in their life and causes significant disability with loss of productive working hours. Low back pain is usually non-specific or mechanical and its mechanical origin is identified by the presence or absence of signs and symptoms i-e local or radicular pain, tenderness, spasm associated with different postures or movements. This study aims to compare the therapeutic effects of shockwave therapy and Maitland lumbar mobilizations on pain, disability and range of motion in patients having mechanical low back pain. Current study will be randomized clinical trial in which convenience sampling technique will be used. Sample size will be 26. Subjects with age group of 25 to 45 years and who meet the inclusion and exclusion criteria will be included in this study and they will be randomly allocated into two groups. Group A will be given shockwave therapy treatment, while the group B will be given Maitland lumbar PA glide mobilizations. Each groups will also receive the conventional physical therapy treatment that includes lumbar stretching exercises and core strengthening exercises. Both the therapeutic techniques will be conducted for 4 weeks, two sessions per week for each group. Before, after two weeks and after four weeks of the treatment sessions, effects of treatment will be noted and quantitative data will be analyzed using SPSS software version 25.

Conditions

Mechanical Low Back Pain

Keywords

low back pain, lumbar mobilization, shockwave therapy

Outcome Measures

Primary Outcomes (3)

• Numerical Pain Rating Scale (NPRS)

  Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain". NPRS have shown high test-retest reliability (r = 0.96 and 0.95, respectively)

  10 Months

• Oswestry Disability Index (ODI)

  The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound

  10 Months

• Bubble Inclinometer

  The simple bubble inclinometer has excellent clinical reliability (ICC \>.90) for measuring lumbar lordosis and thoracic kyphosis in standing.

  10 Months

Study Arms (2)

Shockwave Therapy

EXPERIMENTAL

Common Treatment : Conventional physical therapy (lumbar stretching exercises and core strengthening exercises) Group A: Shockwave Therapy

Device: Shockwave Therapy

Maitland's Lumbar Mobilizations

EXPERIMENTAL

Common Treatment: Conventional Physical Therapy (lumbar stretching exercises and core strengthening exercises) Group B: Maitland's Lumbar mobilizations

Other: Maitland's lumbar mobilizations

Interventions

Shockwave Therapy DEVICE

Subjects in Group A will receive conventional physical therapy treatment that involves lumbar stretching exercises (bridges, knee to chest, press-up back extensions, bird dogs) and core strengthening exercises (partial crunches, pelvic tilts, wall sits, hip stretches) for ten minutes. After the conventional therapy, this group will be given shockwave therapy treatment twice a week for four weeks. After exposing and cleaning the treated area with alcohol, adequate amount of gel will be placed on the lower back region, and the machine will be adjusted at (2000 shock per session, 8 sessions 2 per week for 4 weeks, energy flux density 0,18mJ per mm square, 2 bars of pressure, frequency 10hz), with using 20mm D-Actor head.

Shockwave Therapy

Maitland's lumbar mobilizations OTHER

Subjects in Group B will receive conventional physical therapy treatment that involves lumbar stretching exercises (bridges, knee to chest, press-up back extensions, bird dogs) and core strengthening exercises (partial crunches, pelvic tilts, wall sits, hip stretches) for ten minutes. After the conventional treatment, Group B will be given Maitland's lumbar postero-anterior glide mobilizations initiating from Grade 1, with 3-4 sets of oscillations of 40 counts in each set, 2 sets of oscillations will be given below and above the affected joint level.This whole mobilization treatment will also be given twice a week for 10 minutes.

Maitland's Lumbar Mobilizations

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 25-45 years
• Gender: both male and female
• Patients that reports in physiotherapy OPD or referred from orthopedic department, diagnosed with mechanical low back pain having pain for more than 2 weeks.

You may not qualify if:

• Patients with surgical interventions to lumbar vertebral region.
• Spondylosis
• Disc prolapse
• Spondylolisthesis
• Spinal tumor or inflammatory disease such as rheumatism

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Bin Inam's Clinic

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (6)

• Baig AAM, Ahmed SI, Ali SS, Rahmani A, Siddiqui F. Role of posterior-anterior vertebral mobilization versus thermotherapy in non specific lower back pain. Pak J Med Sci. 2018 Mar-Apr;34(2):435-439. doi: 10.12669/pjms.342.12402.

  PMID: 29805422 BACKGROUND

• Bhat P V, Patel VD, Eapen C, Shenoy M, Milanese S. Myofascial release versus Mulligan sustained natural apophyseal glides' immediate and short-term effects on pain, function, and mobility in non-specific low back pain. PeerJ. 2021 Mar 15;9:e10706. doi: 10.7717/peerj.10706. eCollection 2021.

  PMID: 33777508 BACKGROUND

• Guo X, Li L, Yan Z, Li Y, Peng Z, Yang Y, Zhang Y, Schmitz C, Feng Z. Efficacy and safety of treating chronic nonspecific low back pain with radial extracorporeal shock wave therapy (rESWT), rESWT combined with celecoxib and eperisone (C + E) or C + E alone: a prospective, randomized trial. J Orthop Surg Res. 2021 Dec 4;16(1):705. doi: 10.1186/s13018-021-02848-x.

  PMID: 34863239 BACKGROUND

• Shah SG, Kage V. Effect of Seven Sessions of Posterior-to-Anterior Spinal Mobilisation versus Prone Press-ups in Non-Specific Low Back Pain - Randomized Clinical Trial. J Clin Diagn Res. 2016 Mar;10(3):YC10-3. doi: 10.7860/JCDR/2016/15898.7485. Epub 2016 Mar 1.

  PMID: 27134987 BACKGROUND

• Babina R, Mohanty PP, Pattnaik M. Effect of thoracic mobilization on respiratory parameters in chronic non-specific low back pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2016 Feb 19;29(3):587-95. doi: 10.3233/BMR-160679.

  PMID: 26966825 BACKGROUND

• Riley SP, Tafuto V, Cote M, Brismee JM, Wright A, Cook C. Reliability and relationship of the fear-avoidance beliefs questionnaire with the shoulder pain and disability index and numeric pain rating scale in patients with shoulder pain. Physiother Theory Pract. 2019 May;35(5):464-470. doi: 10.1080/09593985.2018.1453004. Epub 2018 Mar 20.

  PMID: 29558227 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Saba Rafique, ppdpt

  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
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: March 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)