Swimming Versus Standard Physiotherapy Care as Rehabilitation Modalities for Persistent Low Back Pain: Feasibility Study

NCT06423755 | Completed

• 1 other identifier: 264307
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Study four: A small scale RCT will be conducted to pilot the swimming lessons developed in study three, to compare the lessons to standard physiotherapy care and to assess the feasibility of conducting a large RCT in the future. The results from this feasibility study will give the researcher some initial feedback on the swimming lessons and will inform and support the development of an RCT in the future; if the initial findings are positive. This will include whether an RCT can be carried out and evaluating recruitment and retention rates, willingness to be randomised, adverse events, outcomes, acceptability and cost analysis.

Conditions

Chronic Low-back Pain

Keywords

Rehabilitation; Swimming; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Pain Self efficacy questionnaire

  10 questions scored on a Likert scale asking the participant how confident they are to do an activity despite the pain.

  Baseline, 3 weeks and 6 months

Secondary Outcomes (2)

• Oswestry low back pain disability index

  Baseline, 3 weeks and 6 months

• EQ-5D-3L

  Baseline, 3 weeks and 6 months

Study Arms (2)

Swimming programme

EXPERIMENTAL

Participants allocated to the swimming programme will be invited to complete three short questionnaires to assess general health, back pain, and swimming ability and experience, see Appendix H, I and J. Both the swimming and physiotherapy groups will complete the three outcome measures, the Oswestry low back pain disability index (ODI), the pain self-efficacy questionnaire (PSEQ), and the EQ-5D-3L, before the intervention, after the last appointment and 6 months later. Data will be collected to report participant characteristics: including age, gender, and length of time with LBP. A follow up participant feedback questionnaire will be distributed to the participants in the swimming arm on completion of the programme and 6 months later.

Other: Swimming programme

Standard Physiotherapy care

ACTIVE COMPARATOR

The participants in the physiotherapy arm will attend the physiotherapy department in the hospital. Treatment delivered by the physiotherapist could include exercise, advice, education, and manual therapy; they will be offered up to 6 sessions. Some appointments will be delivered in a cubicle and others in the physiotherapy gym. The time between appointments varied from person to person.

Other: Standard Physiotherapy care

Interventions

Swimming programme OTHER

A session plan will be followed, which included aims, objectives, learning outcomes and suggested core aquatic skills and swimming activities under each section. The session will consist of a session brief, a warmup, core aquatic skills, swimming strokes (front crawl, backstroke, breaststroke, and hybrid strokes), a cool down and a session debrief; following the guidance developed in study three.

Swimming programme

Standard Physiotherapy care OTHER

Treatment delivered by the physiotherapist could include exercise, advice, education, and manual therapy; they will be offered up to 6 sessions.

Standard Physiotherapy care

Eligibility Criteria

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

Sponsors & Collaborators

• Canterbury Christ Church University: lead
• East Kent Hospitals University NHS Foundation Trust: collaborator

Study Sites (1)

David Stephensen

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Related Publications (1)

• Oakes H, de Vivo M, Mills H, Stephensen D. Recommending swimming to people with low back pain: A scoping review. J Bodyw Mov Ther. 2023 Oct;36:274-281. doi: 10.1016/j.jbmt.2023.05.012. Epub 2023 Aug 25.

  PMID: 37949572 RESULT

Study Officials

• Hayley Mills, PhD

  Canterbury Christ Church University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomised comparative trial design

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)