Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

— OSCAR  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05120921
• Other study ID #: OSCAR_LBP
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: University College of Osteopathy
• Contact: Jerry RF Draper-Rodi, D.Prof.(Ost)
• Phone: +44 (0)20 7089 5330
• Email: Jerry.Draper-Rodi[@]uco.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Osteopathic Manual Treatment
includes touch, joint manipulations, stretching and massage
• Self-management
Providing rehabilitative exercises to patients to do at home
• Reassurance
Reassuring patients on their symptoms, diagnosis and prognosis.
• Biopsychosocial management
Giving a central place to the patient in the decision-making to help them to get back to valued activities.

Locations

Country	Name	City	State
United Kingdom	University College of Osteopathy	London

Sponsors (2)

Lead Sponsor	Collaborator
University College of Osteopathy	Osteopathic Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Draper-Rodi J, Vogel S, Bishop A. Effects of an e-learning programme on osteopaths' back pain attitudes: a mixed methods feasibility study. Pilot Feasibility Stud. 2021 Sep 13;7(1):174. doi: 10.1186/s40814-021-00901-4. — View Citation

Draper-Rodi, J., Vogel, S. and Bishop, A., 2018. Design and development of an e-learning programme: An illustrative commentary. International Journal of Osteopathic Medicine, 29, pp.36-40.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survey about experience of osteopathic treatment and of participating in the SCED study (for patients)	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.	6 weeks
Other	Prognostic surveys (for the osteopaths)	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.	6 weeks
Other	Survey of SCED feasibility and acceptability and impact of the e-learning course on patient care (for the osteopaths)	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.	9 months
Primary	Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 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.	Up to 18 weeks
Primary	The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 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.	Up to 18 weeks
Secondary	Measure Your Medical Outcome Profile 2	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.	Up to 18 weeks
Secondary	The Arthritis Research UK Musculoskeletal Health Questionnaire	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.	Up to 18 weeks
Secondary	The Depression, Anxiety, and Positive Outlook Scale	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.	Up to 18 weeks
Secondary	The Pain Attitudes and Beliefs Scale (for the osteopaths)	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 speci?c 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 in?uenced 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 a Biomedical domain 0.84; Cronbach's a behavioural domain is 0.68).	6 months