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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05708781
Other study ID # IE/IIMS&R/2022/43
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2022
Est. completion date September 28, 2023

Study information

Verified date January 2023
Source Najran University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.


Description:

The study will be based on a three-arm parallel group randomized control design. Forty-five participants with chronic non-specific low back pain will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups A, B, and C. Experimental group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and core strengthening exercises while group B will receive the hot pack, active Stretching, isometric exercise intervention, and intensive dynamic back exercises, control group C will receive the hot pack, active Stretching, isometric exercise intervention.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 28, 2023
Est. primary completion date August 17, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - age 20-50 years - chronic low back pain (>3 months), Exclusion Criteria: - Participants with low back pain related to cancer, - infection, - inflammatory arthropathy, - high-velocity trauma, - fracture - low back pain associated with severe or progressive neurological deficits trauma - pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Core strengthening exercise
Isolated lumbar stabilization muscle training: Bridge track: Dead bug track: Quadruped Track: Supine Track: Side-support Track: Prone Track: Standing Track:
intensive dynamic back exercise
Trunk lifting Prone on a couch, hips at the edge, upper part of the body free but supported by the hands against the floor. Strap fixation over the calves. With hands on the forehead, the trunk is lifted to the greatest possible extension in hips and spine. If necessary, starting with support from physical therapist. During pauses a chair in front of the couch supports the patient. Leg lifting Standing by the end of the couch, leaning over to a prone position with the hips against the edge in 90 degree flexion, knees 45 degree and feet on the floor. Strap fixation over the chest. Straps around knees to keep legs together. Both legs are straightened and lifted to the greatest possible extension in hips and spine. Again support from physical therapist is necessary. Pull to neck Sitting on a tool with the arms straight and abducted over the head and hands grasping a weight lever. Against sub-maximal resistance the lever is pulled behind neck and shoulders.
Control group
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.

Locations

Country Name City State
India Integral University Hospital Lucknow Uttar Pardesh
Saudi Arabia Hashim Ahmed Najran Najran

Sponsors (1)

Lead Sponsor Collaborator
Najran University

Countries where clinical trial is conducted

India,  Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain 6 Weeks
Primary functional Limitation Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability. 6 Weeks
Primary Muscle Endurance Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test. The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position. 6 Weeks
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