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Osteopathic Single CAse Research for Patients With Chronic Low Back Pain (OSCAR)

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Osteopathic Manual Treatment
Self-management
Reassurance
Biopsychosocial management
Sponsored by
University College of Osteopathy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University College of OsteopathyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

standard osteopathic manual treatment

biopsychosocially informed osteopathic manual treatment

Arm Description

Pragmatic individualised osteopathic manual treatment which is a system of diagnosis and treatment for a wide range of musculoskeletal conditions. Osteopaths take a detailed case history and perform a thorough clinical examination to help understand the nature of patients' pain and symptoms so that they can arrive at a diagnosis. Practitioners use touch, physical manipulation, stretching and massage to help increase the mobility of joints, to relieve muscle/joint tension and pain. Osteopaths often combine a range of other treatment techniques in their approach, such as rehabilitative exercises, advice about how patients can self-manage their condition and educational approaches to help them understand their pain. Osteopathy is a regulated profession (regulated by the General Osteopathic Council) in the UK

As for the active comparator + biopsychosocial management: after having a completed a 8-10 hour e-learning on the biopsychosocial model for the management of low back pain, osteopaths will use the same approaches as in the active comparator group, plus techniques to help patients making sense of their symptoms, to develop patients' self-efficacy, and psychosocial management skills.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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 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).

Full Information

First Posted
October 21, 2021
Last Updated
November 2, 2021
Sponsor
University College of Osteopathy
Collaborators
Osteopathic Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05120921
Brief Title
Osteopathic Single CAse Research for Patients With Chronic Low Back Pain
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College of Osteopathy
Collaborators
Osteopathic Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The first group of patients will receive standard osteopathic management. The second group will receive biopsychosocially informed osteopathic management.
Masking
Outcomes Assessor
Masking Description
The statistician will be blinded to which group patients were allocated to.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard osteopathic manual treatment
Arm Type
Active Comparator
Arm Description
Pragmatic individualised osteopathic manual treatment which is a system of diagnosis and treatment for a wide range of musculoskeletal conditions. Osteopaths take a detailed case history and perform a thorough clinical examination to help understand the nature of patients' pain and symptoms so that they can arrive at a diagnosis. Practitioners use touch, physical manipulation, stretching and massage to help increase the mobility of joints, to relieve muscle/joint tension and pain. Osteopaths often combine a range of other treatment techniques in their approach, such as rehabilitative exercises, advice about how patients can self-manage their condition and educational approaches to help them understand their pain. Osteopathy is a regulated profession (regulated by the General Osteopathic Council) in the UK
Arm Title
biopsychosocially informed osteopathic manual treatment
Arm Type
Active Comparator
Arm Description
As for the active comparator + biopsychosocial management: after having a completed a 8-10 hour e-learning on the biopsychosocial model for the management of low back pain, osteopaths will use the same approaches as in the active comparator group, plus techniques to help patients making sense of their symptoms, to develop patients' self-efficacy, and psychosocial management skills.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manual Treatment
Other Intervention Name(s)
Osteopathic Manipulative Technique
Intervention Description
includes touch, joint manipulations, stretching and massage
Intervention Type
Other
Intervention Name(s)
Self-management
Other Intervention Name(s)
Therapeutic exercises
Intervention Description
Providing rehabilitative exercises to patients to do at home
Intervention Type
Other
Intervention Name(s)
Reassurance
Other Intervention Name(s)
cognitive reassurance; affective reassurance
Intervention Description
Reassuring patients on their symptoms, diagnosis and prognosis.
Intervention Type
Other
Intervention Name(s)
Biopsychosocial management
Other Intervention Name(s)
Enactive approach
Intervention Description
Giving a central place to the patient in the decision-making to help them to get back to valued activities.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
Description
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.
Time Frame
Up to 18 weeks
Title
The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
Description
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.
Time Frame
Up to 18 weeks
Secondary Outcome Measure Information:
Title
Measure Your Medical Outcome Profile 2
Description
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.
Time Frame
Up to 18 weeks
Title
The Arthritis Research UK Musculoskeletal Health Questionnaire
Description
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.
Time Frame
Up to 18 weeks
Title
The Depression, Anxiety, and Positive Outlook Scale
Description
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.
Time Frame
Up to 18 weeks
Title
The Pain Attitudes and Beliefs Scale (for the osteopaths)
Description
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).
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Survey about experience of osteopathic treatment and of participating in the SCED study (for patients)
Description
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.
Time Frame
6 weeks
Title
Prognostic surveys (for the osteopaths)
Description
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.
Time Frame
6 weeks
Title
Survey of SCED feasibility and acceptability and impact of the e-learning course on patient care (for the osteopaths)
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry RF Draper-Rodi, D.Prof.(Ost)
Phone
+44 (0)20 7089 5330
Email
Jerry.Draper-Rodi@uco.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Hilary Abbey, D.Prof.(Ost)
Phone
+44 (0)20 7089 5330
Email
hilary.abbey@uco.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry RF Draper-Rodi, D.Prof.(Ost)
Organizational Affiliation
University College of Osteopathy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College of Osteopathy
City
London
ZIP/Postal Code
SE1 1JE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Draper-Rodi, D.Prof.(Ost)
Phone
02070895330
Email
Jerry.Draper-Rodi@uco.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Dataset will be made available with the publication or by email request to the PI
IPD Sharing Time Frame
From publication of the results and up to 6 years after trial completion.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to jerry.draper-rodi@uco.ac.uk To gain access, data requestors will need to sign a data access agreement.
Citations:
PubMed Identifier
34517916
Citation
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.
Results Reference
background
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.
Results Reference
background

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Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

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