NCT07282925

Brief Summary

The goal of this clinical trial is to compare Cognitive Functional Therapy (CFT) with Kinetic Control Training (KCT) in participants with non-specific low back pain. The study wants to see which approach helps lower pain, reduce disability and improve movement control. The main questions it aims to answer is

  • Is there difference between Cognitive Functional Therapy and Kinetic control training on pain intensity, disability and movement control in participants with Non Specific Low Back Pain?
  • Is there difference between Cognitive Functional Therapy and Kinetic control training on pain catastrophizing and self-efficacy in participants with Non Specific Low Back Pain? Researcher will compare the both CFT and KCT group to see if one treatment is superior to other in treating participants with non-specific back pain. Participants will
  • Attend treatment sessions based on the group they are placed in.
  • Take session three times each week for eight weeks.
  • They will be asked short questions about their pain, daily activity, and movement throughout the study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
2mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Dec 2025Jul 2026

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

April 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 2, 2025

Last Update Submit

March 29, 2026

Conditions

Keywords

Low Back PainNon Specific Low Back PainChronic Low Back PainCognitive Functional TherapyKinetic Control TrainingPainDisabilityMovement Control

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity Measured by Numeric Pain Rating Scale

    Pain intensity will be measured with an 11 point Numeric Pain Rating Scale that is measured from 0 to 10. 0 is no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain and 7-10 is the most severe pain imaginable.

    It will be measured at baseline, 4 weeks and at 8 weeks.

  • Disability measured by Roland Morris Disability Questionnaire

    Disability will be measured by Roland Morris Disability Questionnaire (RMDQ). The RMDQ is a valid and reliable tool for estimating the level of disability in Low Back Pain patients. It is composed of 24 questions that are to be answered by the patients with answers of either 'Yes' or 'No'. The variation of the total score may range from a score of 0 (no disability) to a score of 24 (maximum disability).

    It will be measured at baseline, 4 weeks and 8 weeks

  • Lumbar Motor Control measured by the Luomajoki Motor Control Test Battery

    To evaluate lumbar motor control, the Luomajoki Motor Control Test Battery is employed. This battery includes six individual tests that examine movement control in various positions such as standing, sitting, quadruped, and prone. Each test is scored either 0 or 1, with a total score of 3 or higher indicates impaired motor control

    baseline, 4 week and 8 week

Secondary Outcomes (2)

  • Catastrophizing pain will be measured by Pain Catastrophizing Scale.

    baseline, 4 weeks and 8 weeks

  • Self-efficacy will be measured by Pain Self Efficacy Scale

    Baseline, 4 weeks and 8 weeks

Study Arms (2)

Cognitive Functional Therapy

EXPERIMENTAL
Behavioral: Cognitive Functional Therapy

Kinetic Control Training

ACTIVE COMPARATOR
Other: Kinetic Control Training

Interventions

Patients will receive 24 sessions. In each session, Standard Physical Therapy will be applied which will be the same in both groups. In Kinetic Control Training (KCT), patients will first undergo direction specific movement control tests. These tests will identify direction-specific movement faults (e.g., flexion, extension, rotation control deficits) that contribute to symptoms. Based on these tests, individualized retraining will be provided to the patients. This retraining will improve control of specific muscles which will help reduce pain and improve disability.

Kinetic Control Training

Patients will receive 24 sessions over a period of 8 weeks. Each session will be of 1 hour 15 minutes. Standard Physical Therapy will be provided in which patient will receive Hot pack with TENS and perform a set of exercises including Curl up, Bird dog and side bridge back exercises for 5 repetitions. Then Cognitive Functional Therapy (CFT) will be applied from day one. CFT is structured into three phases: (1) making sense of pain, (2) exposure with control, and (3) lifestyle changes. Making Sense of Pain : This component reflects the cognitive aspect of Cognitive Functional Therapy. It involves hearing patient's personal narrative about their chronic pain. Exposure with Control: It involves graded exposure to feared movements and functional tasks. Lifestyle Changes: This component focuses on lifestyle factors that contribute to pain and disability. It involves modifying sedentary lifestyle behaviors and encouraging healthy routine.

Cognitive Functional Therapy

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of both sexes
  • Aged between 19 to 39
  • Patients who score 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ) at the time of screening
  • Patients who will have Non-Specific Chronic Low Back pain for at least 3 months duration

You may not qualify if:

  • If the primary pain area is not the lumbar spine.
  • If leg pain is the primary problem.
  • If patient have inflammatory disease.
  • If patient have progressive neurological disease.
  • If patient have red flag disorders (malignancy/cancer, traumas such as fracture).
  • Pregnant females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Physical Therapy Clinic

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nayab Naseem

    Lahore University of Biological and Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

December 15, 2025

Primary Completion (Estimated)

May 25, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

April 2, 2026

Record last verified: 2025-12

Locations