NCT07382232

Brief Summary

Background: Low back pain (LBP) is a leading cause of disability, often requiring primary care management. Objective: To compare the effectiveness of isometric versus isotonic exercise programs for LBP. Methods: Sixty adults with LBP were randomly assigned to two groups. Group A (n=30) performed isometric exercises, infrared therapy, and TENS. Group B (n=30) performed isotonic exercises with the same adjunct therapies. Pain (VAS), disability (MODI), and abdominal endurance were measured pre- and post-intervention. Keywords: Exercise therapy; low back pain; disability evaluation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 25, 2026

Last Update Submit

January 25, 2026

Conditions

Keywords

Exercise therapyLBPDisability

Outcome Measures

Primary Outcomes (1)

  • VAS

    Measured using a 100-mm Visual Analogue Scale , where 0 mm represents "no pain" and 100 mm represents "the worst pain imaginable." Participants marked a point on the line corresponding to their current pain level. The Arabic version of the VAS has been validated as a reliable and responsive tool for pain assessment in clinical populations \[17\].

    4 WEEKS

Secondary Outcomes (2)

  • MODI

    4WEEKS

  • Muscular Endurance

    4WWEKS

Study Arms (2)

arm 1- Group A : Isometric Exercises

EXPERIMENTAL

• Isometric Exercise Group (IEG): This group performed a circuit of three core-stabilizing isometric exercises, each held for 10 seconds with brief rest intervals, for 5 complete repetitions. The exercises included: (a) Isometric Curl-Up, (b) Side Bridge, and (c) Bird Dog. The total dedicated exercise time was approximately 20 minutes per session.

Other: Isometric exercises

arm2- Group B: Isotonic Exercises

EXPERIMENTAL

Isotonic Exercise Group (ITG): This group performed a circuit of three dynamic, strength-oriented isotonic exercises, each completed for 10 repetitions. The exercises included: (a) Bent Knee Sit-Up, (b) Cross Curl-Up, and (c) Prone Back Extension. The total dedicated exercise time was also approximately 20 minutes per session. All exercises were selected and adapted from previously published rehabilitation protocols for CLBP

Other: Isotonic exercises

Interventions

• Isometric Exercise Group (IEG): This group performed a circuit of three core-stabilizing isometric exercises, each held for 10 seconds with brief rest intervals, for 5 complete repetitions. The exercises included: (a) Isometric Curl-Up, (b) Side Bridge, and (c) Bird Dog. The total dedicated exercise time was approximately 20 minutes per session.

arm 1- Group A : Isometric Exercises

• Isotonic Exercise Group (ITG): This group performed a circuit of three dynamic, strength-oriented isotonic exercises, each completed for 10 repetitions. The exercises included: (a) Bent Knee Sit-Up, (b) Cross Curl-Up, and (c) Prone Back Extension. The total dedicated exercise time was also approximately 20 minutes per session. All exercises were selected and adapted from previously published rehabilitation protocols for CLBP \[13\].

arm2- Group B: Isotonic Exercises

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years;
  • Diagnosis of non-specific CLBP, defined as pain localized between the lower rib margin and the gluteal folds persisting for more than three months;
  • Self-reported pain intensity score between 40 mm and 80 mm on a 100-mm Visual Analogue Scale (VAS), indicating moderate to severe pain;
  • Pain experienced on at least three days in the month preceding enrollment, with documented interference in daily activities;
  • A formal referral for physiotherapy management.

You may not qualify if:

  • The presence of "red flag" pathologies (e.g., spinal tumor, infection, fracture); - Neurological signs or symptoms suggestive of radiculopathy or myelopathy;
  • a history of spinal surgery or epidural steroid injections within the previous 12 months;
  • Systemic inflammatory diseases (e.g., rheumatoid arthritis) or major neurological disorders;
  • Pregnancy;
  • Receipt of physiotherapy for low back pain within the last six months;
  • Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or inability to refrain from their use during the study period;
  • Any diagnosed psychiatric condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestine Ahliya University

Bethlehem, West Bank, 3600700, Palestinian Territories

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A: Isometric Exercises Group B: Isotonic Exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Palestine Ahliya University is located in Jabal Daher, Bethlehem, West Bank, Palestine, with a mailing address of PO Box 1041, Bethlehem, ZIP code 90907

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

February 1, 2025

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations