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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)

About this trial

This is an interventional treatment trial for Mechanical Low Back Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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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