Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

N/ACompletedNCT05120921

University College of Osteopathy9 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low-back Pain

Interventions

Osteopathic Manual TreatmentOTHER

includes touch, joint manipulations, stretching and massage

Self-managementOTHER

Providing rehabilitative exercises to patients to do at home

ReassuranceOTHER

Reassuring patients on their symptoms, diagnosis and prognosis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University College of Osteopathy

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Up to 18 weeks

Secondary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.