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

NCT03387228 | Completed DMC

• 1 other identifier: NHRC-422/2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

back pain; low back pain; Explain Pain; Pain education

Outcome Measures

Primary Outcomes (10)

• Feasibility of recruitment 1: Willingness to participate in a clinical trial

  All the consecutive participants presenting at the physiotherapy department will be explained about the study and invited to participate in the study. The number of participants not willing to participate will be recorded with the reason for not wanting to participate. Total number of patients not willing to participate will be recorded with the reasons not to participate.

  During the enrollment

• Feasibility of recruitment 2: Eligibility and recruitment

  The total number of participants screened, found eligible, and recruited will be recorded during the screening and recruitment process. The reasons why the participants were ineligible for inclusion in the study will be recorded for every participant who did not meet the eligibility criteria. If the participants refused to participate in the study, the reasons for refusal will be recorded. Finally, the consent rates will be recorded. The number of participants screened, who were eligible, who consented to participate, who refused to participate, reasons for exclusion and refusal will be reported as frequencies.

  During the enrollment

• Feasibility of blinding the assessor

  By asking the assessor two questions at the end of the follow-up assessment: (1) Did you receive any information that indicated which group the participant belonged to? and (2) How did you receive information about which group the patients belonged to? Assessor's guess if the participants belonged to experimental or control group will be recorded. The responses will be coded as 'correct guess' or 'incorrect guess.' The frequency of "yes" and "no" as the answer to the first question will be counted. The frequency of the correct and incorrect guesses will also be counted. Finally, reasons for guesses will qualitatively analyzed.

  Final assessment at 1 week follow up

• Acceptability of screening procedures and random allocation

  The lead researcher will interview the physiotherapist(s) screening the patients for eligibility by asking the following open-ended question at the end of every week, "Were there any difficulties or challenges in screening and recruiting the participants the past week?" The responses will be recorded as 'Yes' or 'No'. The assessor will ask all the participants during recruitment if randomly allocating one of the two treatments is acceptable to them.

  During the enrollment

• Understanding possible contamination between the groups

  Contamination between the groups will be assessed by asking all the participant of the study the following questions at the follow-up assessment: (1) "Have you talked to other participants in this study about the intervention they are receiving?"; If yes, further ask, "Was your attitude towards the intervention, or intervention changed after talking to one of the participants in the other group?"; (2) "Are you aware of the intervention that any participants in the other group are receiving in the study?"; and (3) Are any of the participants in the other group aware of the type of intervention you are receiving in this study?" Participants in the usual care group will be asked the following question: "Did you read the pain education booklet or watch the video which is one of the components of the intervention group?"

  Final assessment at 1 week

• Credibility and acceptability of the interventions

  It will be assessed using five questions. Responses for each of the five questions will be recorded on a Likert Scale where, 0= "Not at all", 1= "A little bit", 2= "Somewhat", 3= "Quite a bit", 4= "Very much."

  Baseline assessment and follow up 1 week assessment

• Adherence to the intervention

  Adherence to home treatment will be assessed by asking the participants in both groups to maintain a log of home treatment, in which the participants will tick mark a box for every day for a total of five days. Total number of responses will be computed by adding the number of days. Adherence will be computed by summing total number of home interventions in each group, represented by a discrete number. Reasons for non-adherence will be listed and analyzed qualitatively.

  Baseline assessment and final assessment at 1 week

• Satisfaction of treatment

  All the participants in both the groups will be assessed using Patient Global Assessment of Treatment Satisfaction (PGATS) scale.64 65 The question asked will be, ''How satisfied are you overall with the study treatment?'' on a 5-point categorical scale (0 = ''Very dissatisfied''; 1 = ''Dissatisfied''; 2 = ''Neutral or no preference''; 3 = ''Satisfied''; 4 = ''Very satisfied'') at the follow-up assessment point. Mean scores of satisfaction of treatment between the groups will be compared using a t-test.

  Final follow up assessment at 1 week

• Difficulty in understanding the information provided by the physiotherapist.

  All the participants in both the groups will be asked about the difficulty in understanding the information provided by the physiotherapist. The question asked will be, "How difficult was it for you to understand the information provided by the physiotherapist?" using a on a 5-point Likert Scale, where 1= "Very easy", 2= "Easy", 3= "Neither easy nor difficult", 4= "Difficult", 5= "Very difficult."

  Final follow up assessment at 1 week

• Adverse events

  All the participants in both the groups will be asked about any adverse events after the treatment. The adverse events will be recorded as a written down verbatim. The type of adverse events will be recorded. The frequency of adverse events in each group will be compared and reported.

  Post intervention on day 1, and at final assessment at 1 week.

Secondary Outcomes (9)

• Patient-Reported Outcome Measurement Information System (PROMIS) pain interference short form 6b

  Baseline assessment and final assessment at 1 week

• PROMIS pain intensity short form 3b

  Baseline assessment and final assessment at 1 week

• Single-item quality-of-life (QOL) scale

  Baseline assessment and final assessment at 1 week

• Pain Catastrophizing Scale (PCS)

  Baseline assessment and final assessment at 1 week

• Global Rating of Change (GROC)

  Final assessment at 1 week

Study Arms (2)

Pain education group (PEG)

EXPERIMENTAL

Pain education based on Explain Pain developed by Moseley and Butler in 2003.

Other: Pain education

Control group (CG)

ACTIVE COMPARATOR

Evidence based physiotherapy care brief education, superficial heat, massage, and exercise.

Other: Control group

Interventions

Pain education OTHER

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.

Pain education group (PEG)

Control group OTHER

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.

Control group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• any duration with pain,
• pain primarily localized between T12 and gluteal folds,
• age 18 years or older,
• average pain intensity reported as moderate, or severe, or very severe on a PROMIS five- point PROMIS Pain Intensity Short-form Scale over the past week,
• is a Nepalese and is able to understand and speak Nepali fluently.
• Participants with likely specific causes of LBP will be excluded using a triage procedure as suggested by Bardin and colleagues,
• having history of prolonged use of corticosteroid,
• history of malignancy,
• recent history of fever or chills,
• history of other diseases associated with compromise in immune system,
• history of recent spinal surgery or dental procedures,
• history of recent history of trauma to spine or a spine fracture,
• history of bladder and bowel dysfunction,
• history of perineal or saddle anaesthesia,
• history of weakness of lower extremity or loss of sensation in lower extremity. -

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead
• University of Otago: collaborator
• University of Washington: collaborator
• University of South Australia: collaborator

Study Sites (1)

Sahara Physiotherapy Hospital

Kathmandu, 44613, Nepal

Location

Related Publications (2)

• Sharma S, Jensen MP, Moseley GL, Abbott JH. Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. BMJ Open. 2019 Mar 27;9(3):e026874. doi: 10.1136/bmjopen-2018-026874.

  PMID: 30918037 DERIVED

• Sharma S, Jensen MP, Moseley GL, Abbott JH. Pain education for patients with non-specific low back pain in Nepal: protocol of a feasibility randomised clinical trial (PEN-LBP Trial). BMJ Open. 2018 Aug 10;8(8):e022423. doi: 10.1136/bmjopen-2018-022423.

  PMID: 30099402 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Saurab Sharma, MPT

  Kathmandu University School of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor and statistician performing data analysis will be masked for the group allocation of all the participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Feasibility of a two group randomized clinical trial.

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 2, 2018
• Study Start: February 16, 2018
• Primary Completion: April 23, 2018
• Study Completion: April 30, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)