Combining Physiotherapy Group Exercise With Acceptance and Commitment Therapy in Elderly With Chronic Low Back Pain

NCT06148896 | Unknown

• 1 other identifier: RCT_YKC
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This two-armed randomized controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with acceptance and commitment therapy led by physiotherapist (GrExPACT) (experimental intervention) as compared to Group Exercise alone (GrEx) (control intervention) for elderly with chronic low back pain (LBP) whom are stratified as medium or high-risk using the STarT Back Screening Tool on functional recovery as measured by Roland Morris Disability Questionnaire as the primary outcome and a list of secondary outcomes which include Committed Action questionnaire, Chronic Pain Acceptance questionnaire, Patient self-efficacy Questionnaire, Brief Pain Inventory, Patient Specific Functional Scale, Short Physical Performance Battery and a patient satisfaction survey, immediately after a 5-week programme as well as at 3-month follow-up. The list of hypotheses to be tested in this RCT include:

1. 1.For main effect: Intervention H0: The outcome means for the intervention of GrExPACT and GrEx are equal H1: The outcome means for the intervention of GrExPACT and GrEx are not equal
2. 2.For main effect: Time H0: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are equal H1: The outcome means for the time with measuring point at pre-intervention, immediate after the program and at 3 months are not equal
3. 3.For interaction: Intervention x Time H0: There is no interaction between the intervention and time H1: There is interaction between the intervention and time

Conditions

Chronic Low Back Pain

Keywords

Elderly; Chronic non specific low back pain; Group exercise; Acceptance and Commitment therapy led by physiotherapist

Outcome Measures

Primary Outcomes (1)

• Roland Morris Disability Questionnaire

  The Roland Morris Disability Questionnaire is a 24 self-administrated items scale which measures the level of disability of patients with LBP. Items are yes and no response in which the item will score 0 with negative response and score 1 for positive response. The score for the Roland Morris Disability Questionaire is the sum of scores of the items with positive response. A patient score can range from 0 to 24. The higher the score, the greater is the disability.

  Pre-intervention, immediate post-intervention and 3 month post-intervention

Secondary Outcomes (7)

• Committed Action Questionnaire

  Pre-intervention, immediate post-intervention and 3 month post-intervention

• Chronic Pain Acceptance Questionnaire

  Pre-intervention, immediate post-intervention and 3 month post-intervention

• Pain self-efficacy Questionnaire

  Pre-intervention, immediate post-intervention and 3 month post-intervention

• Brief Pain Inventory

  Pre-intervention, immediate post-intervention and 3 month post-intervention

• Patient Specific Functional Scale

  Pre-intervention, immediate post-intervention and 3 month post-intervention

Study Arms (2)

Group Exercise with acceptance and commitment therapy

EXPERIMENTAL

Combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapist (GrExPACT)

Behavioral: GrExPACT

Group Physiotherapy Exercise alone

ACTIVE COMPARATOR

Group Physiotherapy exercise alone (GrEx)

Behavioral: GrEx

Interventions

GrExPACT BEHAVIORAL

Combining physiotherapy group exercise with acceptance and commitment therapy delivered by physiotherapy

Also known as: No other intervention (No drug, No device)

Group Exercise with acceptance and commitment therapy

GrEx BEHAVIORAL

Group physiotherapy exercise

Also known as: No other intervention (No drug, No device)

Group Physiotherapy Exercise alone

Eligibility Criteria

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

You may qualify if:

• Ages ≥ 65;
• Nonspecific LBP for \> 3 month;
• Stratified as medium-risk category (i.e., total score ≥ 4 and sub score ≤ to 3) and high-risk category (i.e., total score ≥ 4 and sub score ≥ 4) using the STarT Back Screening Tool;
• Roland Morris Disability Questionnaire (RMDQ) score ≥ 5 (with reference to the minimal level of detectable change)(30, 31);
• Able to walk with or without assistive aid and with Modified Functional Ambulatory Category ≥ 6 (32);
• Able to read Chinese characters;
• Able to speak and understand Cantonese; and
• Abbreviated mental test (AMT) ≥ 6 (33).

You may not qualify if:

• Specific cause of LBP such as tumor, infection, or apparent neurological deficit;
• Serious uncontrolled co-morbidities or systematic diseases which is contraindicated to exercise;
• Orthopedic condition like recent fracture require immobilization and not fitting for exercise;
• Unstable cardiac, pulmonary, metabolic, and psychological disease requiring acute care;
• Severe cognitive, language or hearing deficits;
• Spinal surgery in the past 12 months as not to confound with effect of surgery;
• People who had prior treatment with ACT at any time; or
• People who had received physiotherapy treatment in the previous 6 months.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

Related Publications (20)

• Verhagen AP, Downie A, Popal N, Maher C, Koes BW. Red flags presented in current low back pain guidelines: a review. Eur Spine J. 2016 Sep;25(9):2788-802. doi: 10.1007/s00586-016-4684-0. Epub 2016 Jul 4.

  PMID: 27376890 BACKGROUND

• National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/

  PMID: 27929617 BACKGROUND

• Vadala G, Russo F, De Salvatore S, Cortina G, Albo E, Papalia R, Denaro V. Physical Activity for the Treatment of Chronic Low Back Pain in Elderly Patients: A Systematic Review. J Clin Med. 2020 Apr 5;9(4):1023. doi: 10.3390/jcm9041023.

  PMID: 32260488 BACKGROUND

• Straube S, Harden M, Schroder H, Arendacka B, Fan X, Moore RA, Friede T. Back schools for the treatment of chronic low back pain: possibility of benefit but no convincing evidence after 47 years of research-systematic review and meta-analysis. Pain. 2016 Oct;157(10):2160-2172. doi: 10.1097/j.pain.0000000000000640.

  PMID: 27257858 BACKGROUND

• Jacobs, C. (2015). Contextual pain management physiotherapy. NPUT center of St Thomas Hospital London UK.

  BACKGROUND

• Godfrey E, Galea Holmes M, Wileman V, McCracken L, Norton S, Moss-Morris R, Pallet J, Sanders D, Barcellona M, Critchley D. Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain. BMJ Open. 2016 Jun 7;6(6):e011548. doi: 10.1136/bmjopen-2016-011548.

  PMID: 27267109 BACKGROUND

• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.

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  BACKGROUND

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  PMID: 23651881 BACKGROUND

• Wong WS, McCracken L, Wong S, Chen PP, Chow YF, Fielding R. The Chinese version of the 8-item Committed Action Questionnaire (ChCAQ-8): A preliminary analysis of the factorial and criterion validity. Psychol Assess. 2016 Jun;28(6):e111-8. doi: 10.1037/pas0000187. Epub 2015 Jul 27.

  PMID: 26214015 BACKGROUND

• Vowles KE, McCracken LM, McLeod C, Eccleston C. The Chronic Pain Acceptance Questionnaire: confirmatory factor analysis and identification of patient subgroups. Pain. 2008 Nov 30;140(2):284-291. doi: 10.1016/j.pain.2008.08.012. Epub 2008 Sep 27.

  PMID: 18824301 BACKGROUND

• Liu Y, Wang L, Wei Y, Wang X, Xu T, Sun J. Validation of a Chinese version of the Chronic Pain Acceptance Questionnaire (CAPQ) and CPAQ-8 in chronic pain patients. Medicine (Baltimore). 2016 Aug;95(33):e4339. doi: 10.1097/MD.0000000000004339.

  PMID: 27537558 BACKGROUND

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  PMID: 16446108 BACKGROUND

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  BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Laerd Statisics. (2018). Mixed ANOVA using SPSS Statistics. Retrieved from https://statistics.laerd.com/spss-tutorials/mixed-anova-using-spss-statistics.php

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  PMID: 24324449 BACKGROUND

Study Officials

• Man Ha Sharon Tsang, Doctor

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kit Chi Yeung

CONTACT

852 35053239; angelinayeungykc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded by informing them that they will participate in one of the two treatment groups that is known to be helpful to their chronic nonspecific back pain but not known which one is better. An independent assessor who is responsible for carrying out the physical test and assist the elderly in filling of the questionnaires will be blinded for the group allocation. The research personnel who is responsible for data entry and statistical analysis will also be blinded for the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This two-armed randomised controlled trial (RCT) aims to investigate the effectiveness of Group Exercise with PACT (GrExPACT experimental intervention) as compared to Group Exercise (GrEx) alone led by physiotherapist (control intervention) for elderly with chronic LBP

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: December 28, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 7, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)