Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic LBP

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06009263
• Collaborator: (none)
• Enrollment: 60
• Arms: 3
• Anticipated Duration (Months): 17.6

Study Details

Study Description

Brief Summary

To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity, lumbar ROM, and CSA of multifidus muscle.

Condition or Disease	Intervention/Treatment	Phase
Mechanical Low Back Pain	Other: Conventional treatment; Other: Open chain segmental control; Other: Closed chain segmental control	N/A

Detailed Description

• To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on pain intensity.

• To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber ROM.

• To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on CSA of multifidus muscle.

• To investigate the effect of adding open versus closed chain segmental control exercises to conventional treatment program on lumber function.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group will receive ultrasound and TENS as conventional treatmentGroup will receive ultrasound and TENS as conventional treatment
• Masking: Single (Participant)
• Masking Description: Group will receive open chain segmental control exercises versus closed chain segmental control exercises
• Primary Purpose: Treatment
• Official Title: Effect of Open Chain Versus Closed Chain Segmental Control Exercises on Cross Sectional Area of Lumbar Multifidus Muscle in Chronic Low Back Pain
• Anticipated Study Start Date: Sep 13, 2023
• Anticipated Primary Completion Date: Aug 13, 2024
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control The participants will receive conventional treatment in the form of TENS and Ultrasound.	Other: Conventional treatment; Application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Experimental: Intervention 1 The participants will receive "open chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.	Other: Open chain segmental control; Application of "open chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.
Experimental: Intervention 2 The participants will receive "closed chain segmental control exercises" plus conventional treatment in the form of TENS and Ultrasound.	Other: Closed chain segmental control; Application of "closed chain segmental control exercises" As well as, application of ultrasound and transcutaneous electrical nerve stimulation "TENS" for mechanical low back pain.

Outcome Measures

Primary Outcome Measures

1. Cross sectional area of multifidus muscle [Pre and Post measurement (12 weeks)]

   Cross sectional area of multifidus muscle

2. Pain intensity [Pre and Post measurement (12 weeks)]

   Measured by VAS (from 0 to 10; 0 means no pain and 10 means worst pain)

Secondary Outcome Measures

1. ROM of lumbar spine [Pre and Post measurement (12 weeks)]

   Measuring ROM of lumbar spine

2. Functional ability of lumbar spine [Pre and Post measurement (12 weeks)]

   Questionnaire for measuring lumbar activities (lower score means better and higher score means worse)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with chronic low back pain from both genders their age will be ranged and divided into three groups from 25-55 years.

2. Participants with chronic low back pain lasting for more than 6 Months.

3. A patient who can follow the command.

4. A patient who can do exercise.

Exclusion Criteria:

1. Low back pain patients with a history of severe neurological disease or orthopedic disease.

2. History of Psychological Disorder.

3. Unhealthy Patient.

4. Pregnant women.

5. Patient with a spinal tumor.

6. History of any operation related to spine. Ex. Vertebral fracture or dislocation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haytham M Elhafez, Professor, Cairo University
• ClinicalTrials.gov Identifier: NCT06009263
• Other Study ID Numbers: REC/007/002763
• First Posted: Aug 24, 2023
• Last Update Posted: Aug 28, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Haytham M Elhafez, Professor, Cairo University: Mechanical LBP; Cross Sectional Area; Multifidus muscle
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Aug 28, 2023