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Completed

NCT Number: NCT05120921

Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

This study aims to collect primary data from patients with low back pain to assess the effect of standard osteopathic management and biopsychosocially-informed osteopathic care using a Single-Case Experimental Design.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College of Osteopathy

London, SE1 1JE, United Kingdom

About this study

After being informed about the study and potential risks, all osteopaths and patient participants giving written consent will be screened for eligibility. When entering the trial, patients will be randomised to early, intermediate or late intervention with either standard osteopathic management or biopsychosocially-informed osteopathic management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 or more years old
  • agree to take part in the study and provide formal online consent after having been assessed as capable of providing informed consent by the osteopath
  • Being fluent enough in English to be able to understand content of consent forms (and participate in osteopathic treatment without an interpreter)
  • Presenting with non-specific low back pain of a duration of a minimum of 12 weeks)
  • NRS score between 5 and 9 on a 11-point scale
  • PSFS score between 2 and 7 at baseline
  • Who can be contacted by email
  • Available for an appointment within two days around the randomisation date

Exclusion criteria

  • Under 18
  • Lacking capacity to give consent
  • Presenting with low back pain with a known or suspected pathological cause (e.g. infection, cancer or fracture)
  • People for whom osteopathic treatment may be contra-indicated (as assessed by the osteopath in the initial consultation) or who disclose information during their course of treatment which requires referral for other medical investigations or care
  • LBP of less than 12 weeks
  • NRS score below 5 or above 9
  • PSFS score above below 2 or above 7
  • Patients providing less than 3 data points during baseline

Treatment and study plan

Osteopathic Manual Treatment

Other

includes touch, joint manipulations, stretching and massage

Other names: Osteopathic Manipulative Technique

Self-management

Other

Providing rehabilitative exercises to patients to do at home

Other names: Therapeutic exercises

Reassurance

Other

Reassuring patients on their symptoms, diagnosis and prognosis.

Other names: cognitive reassurance; affective reassurance

Biopsychosocial management

Other

Giving a central place to the patient in the decision-making to help them to get back to valued activities.

Other names: Enactive approach

Primary outcomes

  1. Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)

    Time frame: Up to 18 weeks

    11-item unidimensional measure of pain intensity. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations will be used, i.e. patients will be presented with the numbers from 0 to 10, with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine,' accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24h". NPRS is an acceptable measure but should not be used on its own as patients with chronic pain find it does not capture the complexity of their pain experience. It has a high test-retest reliability and a good validity. Patients will be asked to complete the NPRS every day, taking approx. 1 min.

  2. The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)

    Time frame: Up to 18 weeks

    PSFS measures functional change in patients with musculoskeletal disorders. Patients choose to list up to 5 activities that they have difficulty with or are unable to perform. They will be asked to continue recording data for the originally chosen activities but can add extra activities if goals change (e.g. due to improving or worsening symptoms). Patients will rate current level of difficulty for each activity on an 11-point scale, where 0 = unable to perform and 10 = able to perform at previous level. Mean averages are calculated by summing the difficulty ratings and dividing by the number of activities. The PSFS is reliable and responsive for patients with chronic low back pain and a Minimum Detectable Change (MDC) is considered to be 3 points for 1 activity or 2 points for the average of 2 or more activities.

Secondary outcomes

  1. Measure Your Medical Outcome Profile 2

    Time frame: Up to 18 weeks

    MYMOP2 is a self-report questionnaire that lists one or two symptoms and one activity affected by the patient's condition. The first activity the patient participant created in PSFS will automatically be entered into the text of MYMOP2. The follow-up questionnaire is shorter but allows addition of a third symptom. MYMOP2 is a validated, sensitive and responsive outcome measure. A minimum clinically important change (MCIC) in score should be between 0.5-1.0, and any change greater than 1.0 is considered clinically significant. Patients will be asked to complete MYMOP2 once a week, taking approx. 5 min.

  2. The Arthritis Research UK Musculoskeletal Health Questionnaire

    Time frame: Up to 18 weeks

    MSK-HQ captures generalised health outcomes that are relevant to patients with a range of musculoskeletal conditions. It achieves high completion rates, excellent test-retest reliability, and has strong convergent validity with reference standards. It includes 14 questions scored on a 0-4 scale (range 0-56, where a higher total score represents better health). A licence has been requested to use the questionnaire online from Oxford University Innovation centre for free. Patients will be asked to complete the MSK-HQ three times, taking approx. 2 minutes.

  3. The Depression, Anxiety, and Positive Outlook Scale

    Time frame: Up to 18 weeks

    DAPOS is a self-administered questionnaire that measures distress and positive affect in chronic musculoskeletal pain populations. It has 11 items: 5 on depression, 3 on positive affect and 3 on anxiety; all answered with a 5-point Likert scale response (ranging from 'almost never' to 'almost all the time'). It has an excellent internal consistency and construct validity in comparison with a variety of measures (SF-36; Pain Catastrophizing Scale; Zung Depression) and an acceptable responsiveness.

  4. The Pain Attitudes and Beliefs Scale (for the osteopaths)

    Time frame: 6 months

    PABS is a 19-item questionnaire with six-point response scales. The questionnaire aims to assess two treatment orientations towards LBP: 'biomedical', where disability and pain are consequences of specific tissue pathology and treatment aims to treat pathology; and 'behavioural', where practitioners believe in a BPS model of disease, in which pain does not have to be a sign of tissue damage and can be influenced by social and psychological factors. There is evidence for content and construct validity, internal consistency, reliability and responsiveness. The modified version of the PABS will be used in this project (Cronbach's α Biomedical domain 0.84; Cronbach's α behavioural domain is 0.68).

Other outcomes

  1. Survey about experience of osteopathic treatment and of participating in the SCED study (for patients)

    Time frame: 6 weeks

    At the end of their course of treatment, patients will be asked to complete a final. This questionnaire has been adapted from the Patient Enablement Index for Back Pain and contains 12 questions to assess patients' perceptions of shared decisions making, treatment outcomes, relevance of the measures and acceptability of the data collection processes.

  2. Prognostic surveys (for the osteopaths)

    Time frame: 6 weeks

    Osteopaths will fill in two surveys, one after the initial visit of a patient and one 6 weeks later. It was previously used to assess physical therapists' ability to accurately prognose their patients.

  3. Survey of SCED feasibility and acceptability and impact of the e-learning course on patient care (for the osteopaths)

    Time frame: 9 months

    It was adapted from the Patient Enablement Index. It consists of 12 questions with 11-point Likert scale response options for agreement and satisfaction and 2 open text questions about osteopaths' experiences of SCED processes and outcomes to guide future training and research, taking approx. 5 minutes.

Sponsors and collaborators

Lead sponsor

University College of Osteopathy

Other

Collaborators

  • Osteopathic Foundation

Registry information

Official study title

OSCAR (Osteopathic Single CAse Research) - Assessing the Effects of Standard and Biopsychosocially-informed Osteopathic Management for Patients With Non-specific Low Back Pain: A Single Case Experimental Design (SCED)

Acronym: OSCAR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2021
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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