Back pain - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

The University of Southampton

Recruitment countries:

United Kingdom

Health condition studied:

Back pain management in orthodox (physiotherapy) and CAM (acupuncture & osteopathy) settings in both the NHS and private settings.
Musculoskeletal Diseases

URL:

Link to the clinical trial website

About the trial

Interventions:

1. Prospective Longitudinal Questionnaire Study: addresses issues that are best suited to quantitative methods, concerning effect sizes, outcome predictors and mediators. This study uses practitioner-completed and patient-completed postal and web-based questionnaires to measure key contextual components and established prognostic indicators at 3 time-points: at baseline (T1 - after the 1st consultation for a new episode of LBP), during the course of treatment (T2 – 2 weeks post-baseline and after at least 2 treatments) and at short-term outcome (T3 - 3 months post-baseline).

Some participants in the quantitative study will be invited to also take part in the nested mixed methods study.

2. The qualitative component of the nested mixed methods study is designed to explore in greater depth patient-practitioner communication and compare this across therapies.
This study will explore whether CAM and orthodox therapists use different verbal communication styles and the extent to which these are more or less effective. The questionnaire study will collect data from a large number of patients and practitioners and allow us to test the effects of non-specific factors from five domains including the patient-practitioner relationship

Key inclusion and exclusion criteria:

• Inclusion criteria: Practitioners:
  1. Registered with the relevant professional body (Osteopaths: General Osteopathic Council, GOsC; Physiotherapists: the Chartered Society of Physiotherapy, CSP; Acupuncturists: British Acupuncture Council, BAcC)
  2. Working in either the NHS or private sector
  3. At least 3 years relatively recent clinical experience of musculoskeletal problems
  4. Treat at least one low back pain patient per week
  
  Patients:
  1. Adult (at least 18 years)
  2. Seeking treatment from a participating practitioner
  3. Score at least 4 on the RMDQ (our primary outcome, described below)
• Exclusion criteria: Practitioners:
  1. Not registered with the relevant professional body
  2. Less than 3 years relevant and recent clinical experience
  
  Patients:
  1. Inability to complete questionnaires in English (waived for Welsh participants to comply with legal and research governance requirements)
  2. Serious underlying pathology (inflammatory arthritis, malignancy)
  3. Practitioner-identified conditions that would prevent the sought treatment being applied (e.g. pregnancy when seeking acupuncture)
  
  

• Age minimum:
• Age maximum:
• Gender: Both

Primary outcomes:

Longitudinal Questionnaire Study; the primary outcome measure will be the Roland and Morris Disability Questionnaire at T1 = baseline (after 1st treatment for new episode of LBP); T2 = during the course of treatment (2 weeks post-baseline); T3 = short-term outcome (3 months post-baseline). The main analysis will be performed by multilevel methods (e.g. REML) using appropriate statistical software (e.g. MLWin) to construct a multi-level regression model taking into account the clustering of individual patients within practitioners. This can be described as a 2-level model in which level 1 = individual patient and level 2 = practitioner. As a secondary aim, the patient outcomes can be modelled as time-varying repeated measures while the non-specific factors remain time-invariant predictors.

Secondary outcomes:

1. Social Role, Disability, Work Disability, Pain, Wellbeing, Satisfaction at T1, T2 and T3
2. Therapeutic alliance (WAIS) at T2
3. Organisational appointments at T1
4. Access
5. Facilities (APS-mp, PSQ)
6. Modalities Duration
7. Treatment beliefs
8. Attitudes to back pain (ABS-mp)
9. Outcome expectations
10. Mediators/prognostic indicators
10.1. Risk complexity for recovery (STarT Back)
10.2. Self-efficacy for pain management
10.3. Adherence to lifestyle advice
10.4. Illness perceptions (Brief IPQ)
These will be measured at the same time points as the primary outcome. We will test for main effects of the predictors (whether each factor predicts outcome and determine relative effect sizes), interaction effects (interactions between non-specific factors and therapy), and mediation effects. Multilevel modelling provides an ideal framework for examining such a complex dataset and testing our hypotheses which involve not only main effects but also complex interactions between the variables.

Nested Qualitative study:
The Roter Interactional Analysis System (RAIS) will be used to generate frequency counts for different categories of utterances and we will combine frequency counts and calculate a ration of patient-centred to doctor-centred talk to produce a patient centered index for each taped consultation T2.1.
We will:
1. Quantitatively compare patient-practitioner interactions on the index of patient centeredness. Assuming scores on the patient-centeredness index are normally distributed, a 3x2 ANOVA will test for effects of therapy (osteopathy, physiotherapy, acupuncture) and healthcare sector (NHS, private) on patient-centeredness.
2. We will integrate the data from this study with the main questionnaire study and conduct regression analyses to test whether patient-centered communication predicts patient outcomes.
3. We will transcribe the consultations and conduct an inductive qualitative analysis exploring the thematic content of talk and taking a more holistic view of the consultations, thus addressing some of the limitations of relying solely on quantitative interactional analysis systems and helping us to capture any unique features of CAM consultations.

Target sample size:

1743

Study type:

Observational

Study design:

This multicentre research comprises two linked observational studies, a prospective longitudinal questionnaire study and a nested mixed methods study (Other)

Contacts:

• Name:
• Address:
• Phone:
• Email:
• Affiliation:

• Name: Susan Eardley
• Address: Building 44 Highfield Campus The University of Southampton
• Phone:
• Email:
• Affiliation:

Technical details

Scientific title:

Mechanisms in Orthodox and Complementary Alternative Medicine (CAM) management of back pain: an observational study

Sources of monetary support:

Arthritis Research UK

Secondary sponsors:

Main ID:

ISRCTN60867554

Secondary ID:

20552

Register:

ISRCTN

Date of registration:

17/02/2025

Date of first enrollment:

01/03/2025

Last refreshed:

6 July 2024