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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04867356
Other study ID # HERF/REC/2021-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date June 1, 2021

Study information

Verified date July 2021
Source Health Education Research Foundation (HERF)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date June 1, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Spinal Stabilization Exercises (SSE)
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.
Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)
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.

Locations

Country Name City State
Pakistan NOSIS clinics Mansehra Pakistan Mansehra

Sponsors (1)

Lead Sponsor Collaborator
Health Education Research Foundation (HERF)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 weeks
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