Home » Trials » SLCTR/2023/001


Open-Label, Randomized Controlled Trial to Investigate Outcome of a Pain Coping Skills Psychological Intervention in Relieving Pain and Psychological Distress in Sinhala-conversant Patients with Chronic Knee Osteoarthritis

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SLCTR Registration Number

SLCTR/2023/001


Date of Registration

11 Jan 2023

The date of last modification

Jan 11, 2023



Application Summary


Scientific Title of Trial

Open-Label, Randomized Controlled Trial to Investigate Outcome of a Pain Coping Skills Psychological Intervention in Relieving Pain and Psychological Distress in Sinhala-conversant Patients with Chronic Knee Osteoarthritis


Public Title of Trial

Open-Label, Randomized Controlled Trial to Investigate the outcome of a Cognitive Behavior Therapy based - Pain Coping Skills Psychological Intervention in Relieving Pain and Psychological Distress in Sinhala-conversant Patients with Chronic Knee Osteoarthritis’


Disease or Health Condition(s) Studied

Chronic knee osteoarthritis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1286-5528


Any other number(s) assigned to the trial and issuing authority

EC-22-067 - Ethics Review Committee, Faculty of Medicine, University of Colombo


Trial Details


What is the research question being addressed?

Will a Cognitive Behavior Therapy (CBT) based pain coping skills group intervention alleviate perceived pain and psychological distress (Depression, Anxiety and Stress) and increase quality of life and coping skills in patients diagnosed with chronic knee osteoarthritis?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Other


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

Study setting(s) Clinical Medicine Academic & Research Centre- National hospital of Sri Lanka.

Randomization

a. Method of randomization - block randomization (1:1 allocation ratio) b. Unit of randomization - Patients with chronic knee osteoarthritis c. Method of sequence generation - computer generated random number table. The software research randomizer. https://www.randomizer.org/ d. Method of allocation concealment Utilize sequentially numbered, sealed, opaque envelopes. These envelopes will be kept in a locked location at the study setting. Each envelop will be opened in sequence once the participant has completed baseline measurements by the trained research assistance not involved in participant recruitment.

Recruitment - Three recruitment methods will be utilized. i. Posting of advertisements/flyers including study information, contact details of the principal investigator and the inclusion criteria at the study site (NHSL notice board, clinic notice boards) inviting patients to self-refer to the study.

ii. Healthcare providers and consultant rheumatologist and rehabilitation (co-investigator) at the study site (NHSL rheumatology clinic, special unit) are able to refer patients to the trained research assistants directly, with patients’ permission. The healthcare providers may also give study brochures to participants.

iii. With the approval of the relevant personnel (e.g., consultant rheumatologist and rehabilitation), potentially eligible patients will be actively identified from NHSL, rheumatology clinic - special unit medical records/clinic books by the research assistants with the help of medical officers at rheumatology and rehabilitation clinic (special unit) and the clinic staff. These patients will be mailed letters inviting participation, followed by a telephone call.

Intervention The pain coping skills group intervention (PCSGI) involves a total of six, six-weekly group sessions, approximately 50-60 minutes each, delivered as a group intervention (37 participants in a group), face to face, by a licensed clinical psychologist (PI). The PCSGI therapist manual provides a session-by-session plan for a Cognitive Behavior Therap (CBT) -based psychological intervention. Participants are provided with handouts to facilitate each session, along with an audio recording to guide relaxation techniques. A clinical psychologist provides instruction in cognitive and behavioural pain coping strategies and also leads participants in guided rehearsals of the coping skills. Participants are asked to engage in homework on the skills to enhance their application in pain-associated situations. The PI (a clinical psychologist) will conduct a discussion with participants before starting each session. This discussion involves reviewing participants’ homework, successes and barriers, and encouraging participants to work to set goals for the application of skills.

The control group will not receive any intervention except their usual treatment in the rheumatology and rehabilitation clinic at NHSL, the participants will get standard therapy consisting of medicine, physiotherapy, and occupational therapy as directed by the consultant rheumatologist

Outcome assessments will be done at baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention)

After the three-month follow-up assessments are finished, participants who were randomly assigned to the WL control group will receive the designed pain coping skills intervention


Inclusion criteria

i. Age 50 or more than 50 years ii. Consultant rheumatologist-confirmed diagnosis of knee osteoarthritis iii. Knee pain for three months or more iv. Overall average knee pain in the last week 40 or more on a 100 mm Visual Analogue Scale v. Participants who are conversant in Sinhala and confirm their ability to read, write, and understand the Sinhala language in order to complete the study measures and understand the content and material delivered through the developed PCSGI sessions, which will be conducted in Sinhala. vi. Access to a telephone or mobile phone to send reminders regarding session attendance and follow- up assessment vii. Participants who are able to read and write, understand and follow the given instructions (e.g., junior secondary education in Sri Lanka - grade 9 or lower in local and international education syllabus)


Exclusion criteria

i. Knee surgery including arthroscopy within the past 6 months ii. Awaiting or planning any back or lower limb surgery within the next 12 months iii. Current or past (within 3 months) oral or intra-articular corticosteroid use iv. Systemic arthritis conditions such as rheumatoid arthritis v. Participation in a psychologically based training program for pain-coping abilities within the previous two years vi. Identified mild cognitive impairment using the Montreal Cognitive Assessment-Sinhala version test score of less than 26 vii. Have received a confirmed diagnosis of a mental illness and any underlying neurological issues from a consultant psychiatrist or a neurologist viii. Patients with cancer pain ix. Utilizing alternative therapy modalities such as Ayurveda medicine, native medicine, homoeopathic medication, acupuncture treatment, or exercises designed specifically for the knee over the past six months and currently.



Primary outcome(s)

1.
  1. Decreased levels of perceived Pain as indicated through the Visual Analogue Scale (VAS)
[

The primary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention)

]
2.
  1. Decreased levels of psychological distress in intervention group participants as indicated through decreased sub-scale scores of depression, anxiety and stress as assessed through the Depression, Anxiety and Stress Scale (DASS-21)
[

The primary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention)

]

Secondary outcome(s)

1.
  1. Increase levels of cognitive and behavioral coping strategies will be measured using the Coping Strategies Questionnaire (CSQ)
[

The secondary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention)

]
2.
  1. Increased levels of Quality of Life will be measured through the World Health Organization Quality of Life Questionnaire
[

The secondary outcomes will be measured at 3-time points: Baseline (prior to the commencement of the intervention), post-intervention (just after termination of the six sessions of the intervention) and follow-up (after 3-months of the termination of the intervention)

]

Target number/sample size

74 participants (37 per arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2023-02-01


Anticipated end date

2023-08-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self-funded


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2022-11-17


Approval number

EC-22-067


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:Ethics Review Committee, Faculty of Medicine, University of Colombo, PO Box 271, Kynsey Road, Colombo 8, Sri Lanka.
Telephone:+94-11-2695300 ext 240
Email: ethicscommitteemfc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Medhavi Gunasekara
Clinical Psychologist
Faculty of Medicine, No. 25, Kynsey Road, Colombo 08, Sri Lanka
+94 76 668 888 1


medhavi.gunasekara@gmail.com

Contact Person for Public Queries

Prof. Piyanjali de Zoysa
Senior Professor
Department of Psychiatry, Faculty of Medicine, No. 25, Kynsey Road, Colombo 08, Sri Lanka
+94 112 695 300 Ext. 211


ptdz@sltnet.lk


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results being reported will be shared after de-identification (text, tables, figures and appendices). The study protocol will also be shared. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, including for individual participant data meta-analysis. Proposals should be directed to medhavi.gunasekara@gmail.com. To gain access, data requesters will need to sign a data access agreement.


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results