Pain Education for Patients With Low Back Pain in Nepal: A Feasibility Study

Summary

The primary aim of this study is to evaluate the feasibility of a full randomized clinical trial for assessing the effects of pain education as an intervention for patients with LBP in a physiotherapy facility in Nepal. The primary objectives of the study are related to feasibility of randomized clinical trial including: (1) willingness to participate in a clinical trial, (2) acceptability of random allocation to one of the two study groups, (3) feasibility of blinding the assessor(s), (4) eligibility and recruitment rates, (5) acceptability of screening procedures, (6) possible contamination between the groups, (7) credibility of pain education for patients with LBP, (8) adherence to intervention, (9) satisfaction of treatment, and (10) difficulty in understanding the content of pain education.

To address the study objectives, an assessor-blinded, two arm randomized feasibility study was designed. Forty patients with LBP will be randomly allocated to one of the two study arms, (1) pain education in the experimental group, and (2) evidence based care in the control group (CG).

Conditions

• Low Back Pain, Mechanical

Interventions

OTHER

Pain education

Pain education intervention we plan to use is based on Explain Pain developed by Moseley and Butler in 2003. The pain education handout and materials produced in Nepali will be proof-read and pre-tested in 5 - 10 Nepalese with LBP as needed, and corrected, if necessary. Dosage: A single (approximately) one hour pain education will be delivered to the PEG. Home advice: A printed handout of the pain education material will be provided only to the study participants in the PEG. Participants will be advised to read them (or have family members read them), followed by walking for 30 minutes.

OTHER

Control group

The control participants will receive physiotherapy care based on the recent clinical practice guidelines. This control group intervention will comprise of: (1) education (advice to remain active); (2) massage to back; (3) superficial heat; and (4) static cycling or (treadmill) walking with the aim to promote physical activity. Although superficial heat is recommended in the acute/subacute LBP, we included this as a common treatment for all types of LBP including chronic LBP, which could be a part of self-management. Duration of treatment: 1 hour. Home advice: Participants will be advised to self-manage their back pain based on the information provided. Home exercise leaflet with emphasis on the value of exercise to increase strength and endurance, followed by a 30 minutes walking.

Sponsors & Collaborators

• University of Otago

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of South Australia

  collaborator OTHER

• Kathmandu University School of Medical Sciences

  lead OTHER

Principal Investigators

• Saurab Sharma, MPT · Kathmandu University School of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-16

Primary Completion

2018-04-23

Completion

2018-04-30

Countries

• Nepal

Study Locations