Chiropractic for Adolescent Low back pain including Manipulation/Manual Therapy. The CALM Study.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: The chiropractic clinicians will deliver usual chiropractic care in the form of massage, mobilization, manipulation, and exercise prescription. 1. The patient participants will receive four consultations, of about 15‐30 minutes each, of which two will be delivered in the first week, and the other two at subsequent weekly intervals. 2. The participants will receive the following interventions: Manipulation For the purpose of this study lumbo‐pelvic manipulation is defined as a localised force of high velocity and low amplitude thrust directed at a spinal joint often resulting in joint cavitation or a cracking sound and/or Mobilisation For the purpose of this study lumbo‐pelvic mobilisation is defined as gentle, controlled movements of the spinal joints within the normal ranges of movement and Advice to stay active This is general advice given to the participant to remain active and continue with normal duties within tolerance and as possible. This is as opposed to bed rest and/or Specific back exercises Tailored exercises provided to an individual participant by the treating chiropractor for their back pain or General exercise Advice to undertake general exercise such as walking or other low impact aerobic activity for 30 minutes on at least 5 days per week and Modification of activities Advice to modify daily activities that are likely to worsen the condition or retard recovery 3. A home exercise and other treatment diary will be administered to monitor compliance with exercises and utilization of other treatments for back pain. CONDITION: Adolescent Low Back Pain PRIMARY OUTCOME: Assessment of feasibility of conducting a larger, fully‐powered, randomized controlled trial. The feasibility of the main study will be determined by assessing the following criteria during the pilot study: ; 1. all chiropractor clinicians recruited within two weeks ; 2. 20 patients recruited within four weeks of placing recruitment notices ; 3. 100% of recruited patients allocated to assigned group ; 4. 90% of patients complete baseline measures within 30 mins ; 5. 85% of patients receive all assigned treatments within three weeks ; 6. 95% of consultations adhere to treatment protocol ; chiropractors ability to successfully deliver the usual and sham intervention, assessed qualitatively through brief survey instrument/telephone interviews ; 7. 100% of treatments deemed safe, in that reported adverse events are benign and transitory ; complete follow‐up in at least 90% of all recruited subjects ; 8. Treatment costs will be assessed ; ; This is a composite primary outcome. Primary outcome is disability using a Roland Morris instrument for disability. Primary outcome is pain using a visual analog scale for pain. SECONDARY OUTCOME: General Health using the SF‐36 Measures of well‐being using the EQ‐5D‐5L. INCLUSION CRITERIA: Aged between 13 and 17 years (inclusive) who have experienced non‐specific low back pain in the last month for at least 14 of those days; and have a Visual Analogue Scale for low back pain of at least 3 out of 10 in the previous 24 hours.
Epistemonikos ID: 706e7dc369a4bfb0b4e6202790e41a3ad70b50f6
First added on: Aug 23, 2024