Manual therapy applied by general practitioners for nonspecific low back pain: results of the ManRück pilot-study.

Background: Nonspecific acute low back pain (LBP) is a common reason for accessing primary care. German guidelines recommend non-steroidal anti-inflammatory drugs and physical activity as evidence-based treatments. Manual Therapy (MT) remains controversial. To increase evidence-based treatment options for general practitioners (GPs), a Pilot-Study was set up to gather information about the required conditions and setting for an RCT. Methods: The open pilot-study assesses recruitment methods for GPs and patients, timelines, data collection and outcomes of treatment immediately (T0) and 1, 6 and 12 weeks after consultation (T1, T2, T3). Inclusion criteria for GPs were: no experience of MT; for patients: adults between 18 and 50 suffering from LBP for less than 14 days.Study process: Patients' control-group (CG) was consecutively recruited first and received standard care. After GPs received a single training session in MT lasting two and a half hours, they consecutively recruited patients with LBP to the intervention group (IG). These patients received add-on MT.Primary outcomes: (A): timelines and recruitment success, (B): assessment tools and sample size evaluation, (C) clinical findings: pain intensity change from baseline to day 3 and time till (a) analgesic use stopped and (b) 2-point pain reduction on an 11-point scale occurred.Secondary outcomes: functional capacity, referral rate, use of other therapies, sick leave, patient satisfaction. Results: 14 GPs participated, recruiting 42 patients for the CG and 45 for the IG; 49% (56%) of patients were women. Average baseline pain was 5.98 points, SD: ±2.3 (5.98, SD ±1.8).For an RCT an extended timeline and enhanced recruitment procedures are required. The assessment tools seem appropriate and provided relevant findings: additional MT led to faster pain reduction. IG showed reduced analgesic use and reduced pain at T1 and improved functional capacity by T2. Conclusions: Before verifying the encouraging findings that additional MT may lead to faster pain reduction and reduced analgesic use via an RCT, the setting, patients' structure, and inclusion criteria should be considered more closely. Trial registration: Number: DRKS00003240 Registry: German Clinical Trials Registry (DRKS) URL: https://www.drks.de/drks_web/. Registration date: 14.11.2011. First patient: March 2012. Funding: the Rut and Klaus Bahlsen Stiftung, Hannover.

Manual Therapy by General Medical Practitioners for Nonspecific Low Back Pain in Primary Care: The ManRück Study Protocol of a Clinical Trial.

BACKGROUND: Nonspecific low back pain (LBP) is a common reason for accessing primary care. Manual therapy (MT) may be an effective treatment, but data from clinical studies including relevant subgroups and clinical settings are sparse. The objective of this article is to describe the protocol of a study that will measure whether an MT protocol provided by general medical practitioners will lead to a faster pain reduction in patients with nonspecific LBP than does standard medical care. METHODS/DESIGN: The study is an experimental pre-/postintervention design. The intervention consists of add-on MT treatment by general medical practitioners who have received MT training but are otherwise inexperienced in mobilization techniques. Participating general medical practitioners (n = 10) will consecutively recruit and treat patients before and after their training, serving as their own internal controls. The primary end point is a combined outcome assessing change in pain score over days 0 to 3 and time until pain is reduced by 2 points on an 11-point numeric pain scale and painkiller use is stopped. Secondary outcomes are patients' functional capacities assessed using a questionnaire, amount of sick leave taken, patient satisfaction, and referrals for further treatment. TRIAL REGISTRATION: German clinical trials register: DRKS-ID DRKS00003240.