Comparative Effects of SWT and Maitland LM in Mechanical LBP
Primary Purpose
Mechanical Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Shockwave Therapy
Maitland's lumbar mobilizations
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Low Back Pain focused on measuring low back pain, lumbar mobilization, shockwave therapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with surgical interventions to lumbar vertebral region.
- Spondylosis
- Disc prolapse
- Spondylolisthesis
- Spinal tumor or inflammatory disease such as rheumatism
Sites / Locations
- Bin Inam's ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Shockwave Therapy
Maitland's Lumbar Mobilizations
Arm Description
Common Treatment : Conventional physical therapy (lumbar stretching exercises and core strengthening exercises) Group A: Shockwave Therapy
Common Treatment: Conventional Physical Therapy (lumbar stretching exercises and core strengthening exercises) Group B: Maitland's Lumbar mobilizations
Outcomes
Primary Outcome Measures
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)
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
Bubble Inclinometer
The simple bubble inclinometer has excellent clinical reliability (ICC >.90) for measuring lumbar lordosis and thoracic kyphosis in standing.
Secondary Outcome Measures
Full Information
NCT ID
NCT05404997
First Posted
May 31, 2022
Last Updated
May 31, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05404997
Brief Title
Comparative Effects of SWT and Maitland LM in Mechanical LBP
Official Title
Comparative Effects of Shockwave Therapy and Maitland's Lumbar Mobilization on Pain, Disability and Range of Motion in Patients With Mechanical Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Low back pain (LBP) is increasingly becoming one of the main health concerns nowadays. It affects daily life and work routine and leads to medical consultations. The prevalence of NSLBP is approximately 10 to 25% in young and middle-aged individuals. Even though degenerative changes are minimal in this age group, more physical activities consequently make this group vulnerable to various physical strains. Approximately 10% of LBP cases have an identifiable pathology, while the remaining 90% are non-specific LBP (NSLBP), reflecting LBP of unknown underlying pathology, characterized by pain, muscle tension, and stiffness between 12th rib and inferior gluteal fold. Based on duration, LBP can be categorized as acute (less than six weeks), sub-acute (six to twelve weeks), and chronic (more than twelve weeks). Common symptom is the pain that gets worse with activity and relieved by rest. There are different methods for LBP treatment like surgery, oral medication, injection at lumbar region, psychotherapy, chiropractic and physiotherapy. Physiotherapy modalities and techniques like electrotherapy, low level laser, ultrasound, massage, shortwave, traction, superficial heat, spinal manipulation and exercise therapy are used to treat such cases. Extracorporeal Shock Wave Therapy (ESWT) has emerged as a popular tool for treatment of musculoskeletal disorders such as lateral epicondylitis, painful shoulder syndrome and plantar fasciitis. The two primary types of shock waves are the Focused Extracorporeal Shock Wave (fESW) and the Radial Extracorporeal Shock Wave (rESW). They differ in terms of the manner and extent of the acoustic energy propagation, the shape of the beam and its physical properties. Maitland mobilization techniques are thought to benefit patients with lumbar mechanical pain through the stimulation of joint mechanoreceptors.
A systematic review and meta-analysis of RCTS was conducted in 2020 to check the effectiveness and safety of extracorporeal shockwave treatment on low back pain. Multiple electronic databases including PubMed, Embase, Cochrane's library, China National Knowledge Infrastructure (CNKI), and Wan Fang Data were searched until December, 2019 to identify studies assessing the effectiveness and safety of EPSW for LBP. The main outcome was pain intensity which was measured using visual analogue scale (VAS) and numeric pain rating scale (NPRS).Functional status, quality of life and psychological outcomes were also measured using oswestry disability index (ODI). Findings of all these studies concluded that the use of focused ESWT is effective in alleviating pain and improving general functional state of patients with low back pain. The effectiveness of Maitland spinal mobilization therapy in the treatment of non-specific low back pain. It was a prospective study that involved ninety (90) subjects who completed the recommended four-week program. All subjects were given spinal mobilization therapy using Maitland method. The conclusions of this study indicated that manual therapy is a consideration in treatment of non-specific LBP and as an alternative to conventional treatment methods.
The effects of shockwave therapy and Maitland lumbar mobilizations have been seen to be the effective approaches in the treatment of mechanical or non-specific low back pain. But these treatment approaches have seen independently in treating low back pain. But there is no literature available that compares the effect of both techniques. So to see the comparative effects of these two techniques will be the main goal of this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
low back pain, lumbar mobilization, shockwave therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shockwave Therapy
Arm Type
Experimental
Arm Description
Common Treatment : Conventional physical therapy (lumbar stretching exercises and core strengthening exercises) Group A: Shockwave Therapy
Arm Title
Maitland's Lumbar Mobilizations
Arm Type
Experimental
Arm Description
Common Treatment: Conventional Physical Therapy (lumbar stretching exercises and core strengthening exercises) Group B: Maitland's Lumbar mobilizations
Intervention Type
Device
Intervention Name(s)
Shockwave Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Maitland's lumbar mobilizations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
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)
Time Frame
10 Months
Title
Oswestry Disability Index (ODI)
Description
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
Time Frame
10 Months
Title
Bubble Inclinometer
Description
The simple bubble inclinometer has excellent clinical reliability (ICC >.90) for measuring lumbar lordosis and thoracic kyphosis in standing.
Time Frame
10 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Patients with surgical interventions to lumbar vertebral region.
Spondylosis
Disc prolapse
Spondylolisthesis
Spinal tumor or inflammatory disease such as rheumatism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saba Rafique, ppdpt
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bin Inam's Clinic
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
saba Rafique
Phone
03034045433
Email
saba.rafique@riphah.edu
First Name & Middle Initial & Last Name & Degree
Rida Ejaz, MSPT-OM
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29805422
Citation
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.
Results Reference
background
PubMed Identifier
33777508
Citation
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.
Results Reference
background
PubMed Identifier
34863239
Citation
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.
Results Reference
background
PubMed Identifier
27134987
Citation
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.
Results Reference
background
PubMed Identifier
26966825
Citation
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.
Results Reference
background
PubMed Identifier
29558227
Citation
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.
Results Reference
background
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Comparative Effects of SWT and Maitland LM in Mechanical LBP
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