Chronic Low-back PainOSCARNCT05120921
Osteopathic Single CAse Research for Patients With Chronic Low Back Pain
A study testing Osteopathic Manual Treatment, Self-management and Reassurance in people with Chronic Low-back Pain, run by University College of Osteopathy at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Osteopathic Manual Treatment, Self-management and Reassurance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2021to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Osteopathic Manual Treatment, Self-management, Reassurance, Biopsychosocial management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manual TreatmentOther
Also called Osteopathic Manipulative Technique
includes touch, joint manipulations, stretching and massage
Self-managementOther
Also called Therapeutic exercises
Providing rehabilitative exercises to patients to do at home
ReassuranceOther
Also called cognitive reassurance; affective reassurance
Reassuring patients on their symptoms, diagnosis and prognosis.
Biopsychosocial managementOther
Also called Enactive approach
Giving a central place to the patient in the decision-making to help them to get back to valued activities.
| Study group | Role | What they receive |
|---|---|---|
| standard osteopathic manual treatment | Active comparator | 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 Receives: Other: Osteopathic Manual Treatment; Other: Self-management; Other: Reassurance |
| biopsychosocially informed osteopathic manual treatment | Active comparator | 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. Receives: Other: Osteopathic Manual Treatment; Other: Self-management; Other: Reassurance; Other: Biopsychosocial management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 weeks
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.
Measured: Up to 18 weeks
Secondary outcomes (4)
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.
Measured: Up to 18 weeks
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.
Measured: Up to 18 weeks
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.
Measured: Up to 18 weeks
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start5 Nov 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The first group of patients will receive standard osteopathic management. The second group will receive biopsychosocially informed osteopathic management.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Osteopathy
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopathic Foundation
- Responsible party
- Sponsor
- Investigators
- Jerry RF Draper-Rodi, D.Prof.(Ost), Principal investigator, University College of Osteopathy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120921
- Sponsor's protocol ID
- OSCAR_LBP
- Acronym
- OSCAR
- Status last verified
- Apr 2025
- First submitted
- 21 Oct 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset will be made available with the publication or by email request to the PI
Publications
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.
PubMed 34517916Draper-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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05120921
- Acronym / sponsor ID
- OSCAR / OSCAR_LBP
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University College of OsteopathyUniversity, hospital or other
- Collaborators
- Osteopathic Foundation
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The first group of patients will receive standard osteopathic management. The second group will receive biopsychosocially informed osteopathic management.
| Arm | Type | Receives |
|---|---|---|
| standard osteopathic manual treatment | Active comparator | Other: Osteopathic Manual Treatment, Other: Self-management, Other: ReassurancePragmatic 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 |
| biopsychosocially informed osteopathic manual treatment | Active comparator | Other: Osteopathic Manual Treatment, Other: Self-management, Other: Reassurance, Other: Biopsychosocial managementAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manual TreatmentAlso: Osteopathic Manipulative Techniqueincludes touch, joint manipulations, stretching and massage | Other | biopsychosocially informed osteopathic manual treatment, standard osteopathic manual treatment |
| Self-managementAlso: Therapeutic exercisesProviding rehabilitative exercises to patients to do at home | Other | biopsychosocially informed osteopathic manual treatment, standard osteopathic manual treatment |
| ReassuranceAlso: cognitive reassurance; affective reassuranceReassuring patients on their symptoms, diagnosis and prognosis. | Other | biopsychosocially informed osteopathic manual treatment, standard osteopathic manual treatment |
| Biopsychosocial managementAlso: Enactive approachGiving a central place to the patient in the decision-making to help them to get back to valued activities. | Other | biopsychosocially informed osteopathic manual treatment |
Primary outcome
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.
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.
4 secondary outcomes
Measure Your Medical Outcome Profile 2
Time frame: Up to 18 weeks
The Arthritis Research UK Musculoskeletal Health Questionnaire
Time frame: Up to 18 weeks
The Depression, Anxiety, and Positive Outlook Scale
Time frame: Up to 18 weeks
The Pain Attitudes and Beliefs Scale (for the osteopaths)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Background: PubMed 34517916Draper-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.
- BackgroundDraper-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.
- Individual participant dataSharing planned: Yes. Dataset will be made available with the publication or by email request to the PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry RF Draper-Rodi, D.Prof.(Ost) principal investigator
University College of Osteopathy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manual Treatment, Self-management and Reassurance in people with Chronic Low-back Pain, run by University College of Osteopathy at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks) (time frame: Up to 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.