NCT06751173

Brief Summary

Chronic back pain is posteriorly occurring multi-causes pain that most commonly occurred due to lumber strains and sprains. It usually lasts 12 weeks (03 months) or longer. It is exacerbated by prolonged sitting, lifting heavy weights and sudden awkward movements. The aim of study will be to compare the effects of static core stability versus extension exercises program on pain, range of motion and functional disability in patients with chronic low back pain. A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore and Jinnah Hospital Lahore through lottery methode technique on 30 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with static core stabilization exercises and Group B will be treated with lumber extension exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, range of motion and functional disability questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

July 15, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

December 20, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

Low back paincore stabilitystrengthing

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rate scale (NPRS)

    The patient's level of pain will be assessed using this scale. The 11-point numeric scale ranges from '0,' representing one pain extreme (e.g., "no pain"), to '10,' representing the other pain extreme (e.g., "pain as bad as can be imagined" or "worst pain imaginable").

    baseline, 8 weeks

  • Osvestry Disability index (ODI)

    This questionnaire will be used to assess disability. The Oswestry Disability Index (ODI) consists of 10 questions completed by the patient, with response options presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).

    baseline, 8 weeks

  • Inclinometer

    The range of motion of the lower back will be measured.

    baseline, 8 weeks

Study Arms (2)

Group A

EXPERIMENTAL

The Group A will be treated with Static Core Stability exercises and common treatment. i. Plank: Press the hands and knees to the floor with the back in a neutral position and wrists aligned directly under the shoulders. ii. Side Plank: Lie on the side with knees bent and prop the upper body up on the elbow. iii. Shoulder Bridge: Raise the pelvis off the floor until only the head, neck, shoulders, and feet are touching the mat. Place the hands at the waist. iv. Static Crunch: Lie on the back with the feet flat on the floor and the knees bent at a 90-degree angle. v. Leg Lift: Lie straight on the floor, keep the arms at the sides, and slowly lift both legs into the air.

Other: Static Core Stability exercisesOther: Spinal Mobilization

Group B

ACTIVE COMPARATOR

The second group will consist of McKenzie exercises with common treatment. i. Prone Extension (Positioned): Lie on the stomach with pillows placed under the chest for comfort. ii. Prone Extension on Elbow: Keep the back and buttocks relaxed and rise up on the elbows as high as possible. iii. Prone Press-ups: Place the hands beside the shoulders. Keep the back and buttocks relaxed, and use the arms to press up. iv. Standing Extension: Stand with feet apart and hands on the small of the back with fingers pointing backward. Bend backward at the waist while supporting the trunk with the hands. v. Sideglide in Standing: Stand at a right angle to the wall about 2 feet away. Lean the shoulder into the wall. Common Treatment: Spinal mobilization with central-unilateral posterior-anterior and lateral glide.

Other: Mckenzie exercisesOther: Spinal Mobilization

Interventions

i. Plank: Press the hands and knees to the floor with the back in a neutral position and wrists aligned directly under the shoulders. ii. Side Plank: Lie on the side with knees bent and prop the upper body up on the elbow. iii. Shoulder Bridge: Raise the pelvis off the floor until only the head, neck, shoulders, and feet are touching the mat. Place the hands at the waist. iv. Static Crunch: Lie on the back with feet flat on the floor and knees bent at a 90-degree angle. v. Leg Lift: Lie straight on the floor, keep the arms at the sides, and slowly lift both legs into the air.

Group A

i. Prone Extension (Positioned): Lie on the stomach with pillows placed under the chest for comfort. ii. Prone Extension on Elbow: Keep the back and buttocks relaxed and rise up on the elbows as high as possible. iii. Prone Press-ups: Place the hands beside the shoulders. Keep the back and buttocks relaxed, and use the arms to press up. iv. Standing Extension: Stand with feet apart and hands on the small of the back with fingers pointing backward. Bend backward at the waist, supporting the trunk with the hands. v. Side glide in Standing: Stand at a right angle to the wall about 2 feet away. Lean the shoulder into the wall.

Group B

Central-Unilateral posterio anterior and lateral glide

Group AGroup B

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Minimum 03 months of chronicity of low back pain.
  • No radiating leg pain.
  • Moderate pain (NPRS: 3-7)
  • Disability score of 19% or greater as evident from the modified Oswestry Disability Questionnaire (MODQ)
  • Positive prone instability test

You may not qualify if:

  • Chronic systemic boney and soft tissue.
  • Recent history of trauma.
  • Degenerative joint diseases
  • Psychiatric diseases.
  • Ongoing radiotherapy, chemotherapy and steroid therapy.
  • Localized infection in lumbar region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehab Training and Research Center

Lahore, Punjab Province, 54760, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maryam Arshad, DPT

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

July 15, 2024

Primary Completion

December 30, 2024

Study Completion

January 30, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations