Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Primary Purpose
Mechanical Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Spinal Stabilization Exercises (SSE)
Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- male and female
- 20 to 60 years
- chronic mechanical low back pain
Exclusion Criteria:
- patients who had any type of injury or fracture which limits rehabilitation
- patients with the symptoms of radiating pain
- who had disc pathology and spinal cord injury
- patients with medical conditions
Sites / Locations
- NOSIS clinics Mansehra Pakistan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Spinal Stabilization Exercises (SSE)
Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
Arm Description
Outcomes
Primary Outcome Measures
Oswestry disability index
The Oswestry Disability Index (aka 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 has been around since 1980 and is considered the 'gold standard' of low back pain functional outcome tools. SCORE DISABILITY LEVEL 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an ex- tremely important tool that researchers and disability evaluators use
Secondary Outcome Measures
Full Information
NCT ID
NCT04867356
First Posted
April 27, 2021
Last Updated
July 4, 2021
Sponsor
Health Education Research Foundation (HERF)
1. Study Identification
Unique Protocol Identification Number
NCT04867356
Brief Title
Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Official Title
Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Health Education Research Foundation (HERF)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain
Detailed Description
A single-blinded,randomized clinical trial will be conducted in /multiple rehabilitation centers of Rawalpindi and Islamabad, after taking approval from ERB/IRB respective centers. The study duration will be 3 months. the study participants will be having mechanical low back pain.
The intervention will be included latissmus dorsi stretching along with spinal stabilization exercises in one group and in comparative group spinal stabilization exercises alone. Oswestry Disability Index (ODI) will be used to measure the disability related to the chronic low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Stabilization Exercises (SSE)
Arm Type
Active Comparator
Arm Title
Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Spinal Stabilization Exercises (SSE)
Intervention Description
Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients.
Home exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc.
Intervention Type
Other
Intervention Name(s)
Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
Intervention Description
In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session.
Primary Outcome Measure Information:
Title
Oswestry disability index
Description
The Oswestry Disability Index (aka 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 has been around since 1980 and is considered the 'gold standard' of low back pain functional outcome tools. SCORE DISABILITY LEVEL 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an ex- tremely important tool that researchers and disability evaluators use
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male and female
20 to 60 years
chronic mechanical low back pain
Exclusion Criteria:
patients who had any type of injury or fracture which limits rehabilitation
patients with the symptoms of radiating pain
who had disc pathology and spinal cord injury
patients with medical conditions
Facility Information:
Facility Name
NOSIS clinics Mansehra Pakistan
City
Mānsehra
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects Of Latissimus Dorsi Stretching On Functional Disability Related To Chronic Low Back Pain
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