ESCAPE-pain Programme in Malaysia

NCT03379623 | Completed DMC

• 1 other identifier: 2017-2045-3627
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The overall aim of this study is to develop an evidence based exercise programme for the management of knee osteoarthritis which is feasible and acceptable to patients and healthcare professionals in Malaysia. The chosen programme was identified through a systematic literature search and is the programme developed by Hurley et al. in 2007. This programme will be evaluated through mixed-methods sequential exploratory design research study guided by the United Kingdom (UK) Medical Research Council guidance and framework. It involves two phases of data collection. The first phase (already completed) comprised a qualitative study aimed at exploring the beliefs and attitudes of Malaysian people that would need to be taken into account when adapting the evidence based ESCAPE-pain (acronym for 'Enabling Self-management and Coping with Arthritic pain using Exercise) programme for implementation in the context of Malaysian healthcare system. The second phase will be conducted to evaluate the feasibility of trialling ESCAPE-pain programme in Malaysia.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 and 12 weeks

  The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.

Secondary Outcomes (5)

• Change of Baseline Timed up and Go Test at 6 and 12 weeks

  Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.

• Change of Baseline Health Beliefs and Self-efficacy for exercise at 6 and 12 weeks

  Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.

• Change of Baseline The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) at 6 and 12 weeks

  Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.

• Change of Baseline Short Falls Efficacy Scale-International (FES-I) at 6 and 12 weeks

  Baseline, after intervention completion at week 6, and at week 12 of intervention for follow-up.

• Exercise Adherence Rating Scale (EARS)

  Week 12 of intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: ESCAPE-pain Programme

Usual care group

NO INTERVENTION

Interventions

ESCAPE-pain Programme OTHER

The Enabling Self-management and Coping with Arthritic (knee) Pain using Exercise (ESCAPE-pain) is a programme of rehabilitation that integrates educational self-management and coping strategies for people with joint pain with an individualised exercise regimen for each participant. The implementation of the programme will be conducted by the researcher as a certified facilitator by using Clinician's training manual for the ESCAPE-pain programme.

Intervention group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 years or older (one of the criteria to diagnose knee osteoarthritis by a medical officer based on Ministry of Health Malaysia guidelines (MoH, 2014)).
• Diagnosed with osteoarthritis affecting the knee by medical officer based on Clinical Practice Guidelines (CPG) MOH (MOH, 2014).
• Independently mobile either with or without walking aid.
• Approved medically fit for exercise by a medical officer.
• Able to communicate in Malay language.
• Must have mental capacity to give informed consent.

You may not qualify if:

• Had knee replacement / lower limb arthroplasty.
• Intraarticular injections within past six months.
• Have any significant musculoskeletal issues (e.g. inflammatory arthritis, connective tissue diseases, fibromyalgia, severe osteoporosis, peripheral neuropathy, or gout).
• Very severe joint pain which limiting mobility to less than 50 metres.
• people with unstable co-morbidities (such as cardiovascular and respiratory conditions, type 2 diabetes, severe pain in other joints).
• wheelchair user.
• severe cognitive impairment assessed by a medical officer.
• severe auditory or visual impairment assessed by a medical officer.
• inability to comprehend the ESCAPE-pain procedure

Sponsors & Collaborators

• Muhammad Kamil Che Hasan: lead

Study Sites (2)

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

IIUM Medical Centre

Kuantan, Pahang, 25200, Malaysia

Location

Related Publications (7)

• Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Patel A, Williamson E, Jones RH, Dieppe PA, Reeves BC. Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial. Arthritis Rheum. 2007 Oct 15;57(7):1211-9. doi: 10.1002/art.22995.

  PMID: 17907147 BACKGROUND

• Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Williamson E, Jones RH, Reeves BC, Dieppe PA, Patel A. Economic evaluation of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain. Arthritis Rheum. 2007 Oct 15;57(7):1220-9. doi: 10.1002/art.23011.

  PMID: 17907207 BACKGROUND

• Jessep SA, Walsh NE, Ratcliffe J, Hurley MV. Long-term clinical benefits and costs of an integrated rehabilitation programme compared with outpatient physiotherapy for chronic knee pain. Physiotherapy. 2009 Jun;95(2):94-102. doi: 10.1016/j.physio.2009.01.005. Epub 2009 Mar 21.

  PMID: 19627690 BACKGROUND

• Hauer KA, Kempen GI, Schwenk M, Yardley L, Beyer N, Todd C, Oster P, Zijlstra GA. Validity and sensitivity to change of the falls efficacy scales international to assess fear of falling in older adults with and without cognitive impairment. Gerontology. 2011;57(5):462-72. doi: 10.1159/000320054. Epub 2010 Oct 22.

  PMID: 20975251 BACKGROUND

• Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.

  PMID: 27913064 BACKGROUND

• Zulkifli MM, Kadir AA, Elias A, Bea KC, Sadagatullah AN. Psychometric Properties of the Malay Language Version of Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire among Knee Osteoarthritis Patients: A Confirmatory Factor Analysis. Malays Orthop J. 2017 Jul;11(2):7-14. doi: 10.5704/MOJ.1707.003.

  PMID: 29021872 BACKGROUND

• Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.

  PMID: 19228398 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be performed by an independent person from Kulliyyah of Nursing research unit. The researcher will not be involved in allocation to intervention or control group. The participants will be advised not to talk about the study during assessments to prevent unblinding.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 20, 2017
• Study Start: October 12, 2017
• Primary Completion: January 5, 2018
• Study Completion: February 28, 2018
• Last Updated: May 3, 2018

Record last verified: 2018-05

Locations

MY (2)