NCT07284407

Brief Summary

The current study is a double-blind, parallel-group randomized controlled trial involving 80 participants with chronic low back pain. The trial will compare a program of Pain Neuroscience Education plus Sensory Discrimination Training and core stability exercises with a program of Pain Neuroscience Education and core stability exercises alone. Interventions will be delivered twice weekly for eight weeks. The primary outcome is pain catastrophizing. Secondary outcomes include kinesiophobia and functional movements. Assessments will be conducted at baseline, 4, and 8 weeks. The trial will be carried out at Nutricao Lahore Clinic and Model Town Hospital, Lahore. The hypothesis is that Pain Neuroscience Education with Sensory Discrimination Training will result in greater reductions in pain catastrophizing and kinesiophobia, as well as improvements in functional movements.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

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

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable low-back-pain

Status
not yet 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

First Submitted

Initial submission to the registry

November 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 16, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 17, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Pain CatastrophizingKinesiophobiaFunctional movementsNeuroscience pain education

Outcome Measures

Primary Outcomes (1)

  • Pain Catastrophizing

    Pain catastrophizing refers to a maladaptive cognitive and emotional response to actual or perceived pain. Pain Catastrophizing is measured by the Pain Catastrophizing Scale. The Pain Catastrophizing Scale is a validated questionnaire used to measure the degree of catastrophic thinking in individuals experiencing pain (Sullivan et al. 1995). The scale consists of 13 items, each representing a different catastrophizing response. For each item, participants rate their experience using a 5-point Likert scale, where 0 = Not at all (the thought or feeling never occurred) and 4 = All the time (the thought or feeling occurred persistently). The total score ranges from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Kinesiophobia

    From enrollment to the end of treatment at 8 weeks

  • Functional Movements

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in the experimental group will receive a 45-minute intervention session consisting of three integrated components (Pain Neuroscience Education, Core Stability Exercises and Graded Sensory Discrimination Training )

Other: Pain Neuroscience Education with Sensory Discrimination Training and Core Stability Exercises

Control group

ACTIVE COMPARATOR

Participants in the control group will receive the same 45-minute sessions consisting of two components (Pain Neuroscience Education and Core Stability Exercises).

Other: Pain Neuroscience Education and Core stability Exercises

Interventions

Although both Pain Neuroscience Education and Sensory Discrimination Training have demonstrated potential benefits individually, there is a paucity of research evaluating their combined effects. Integrating cognitive (PNE) and sensorimotor (SDT) approaches may produce synergistic effects, improving pain modulation, functional capacity, and psychological resilience.

Experimental Group

Participants in the control group will receive the same 45-minute sessions twice per week, but will not receive sensory discrimination training.

Control group

Eligibility Criteria

Age19 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 19 to 44 Both Genders Mechanical low back pain (duration more than 6 months and less than 2 years) \>4/10 Numerical Pain Rating Scale (NPRS)

You may not qualify if:

  • Pregnancy or post-partum Trauma Psychological Pain Radicular Pain Cancer, tumor, malignancy Neurological Deficit Recent Surgery \<1year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainKinesiophobia

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • MUHAMMAD TARIQ RAFIQ

    Lahore University of Biological & Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD SAAD JANJUA

CONTACT

MUHAMMAD TARIQ RAFIQ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 17, 2025

First Posted

December 16, 2025

Study Start

December 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
It will be available after the completion of the study.
Access Criteria
Through the corresponding author.