Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: Study protocol of a randomized clinical trial [NCT00257998]

BACKGROUND: Recently a clinical prediction rule (CPR) has been developed and validated that accurately identifies patients with low back pain (LBP) that are likely to benefit from a lumbo-pelvic thrust manipulation. The studies that developed and validated the rule used the identical manipulation procedure. However, recent evidence suggests that different manual therapy techniques may result similar outcomes. The purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the CPR. METHODS/DESIGN: Consecutive patients with LBP referred to physical therapy clinics in one of four geographical locations who satisfy the CPR will be invited to participate in this randomized clinical trial. Subjects who agree to participate will undergo a standard evaluation and complete a number of patient self-report questionnaires including the Oswestry Disability Index (OSW), which will serve as the primary outcome measure. Following the baseline examination patients will be randomly assigned to receive the lumbopelvic manipulation used in the development of the CPR, an alternative lumbar manipulation technique, or non-thrust lumbar mobilization technique for the first 2 visits. Beginning on visit 3, all 3 groups will receive an identical standard exercise program for 3 visits (visits 3,4,5). Outcomes of interest will be captured by a therapist blind to group assignment at 1 week (3(rd )visit), 4 weeks (6(th )visit) and at a 6-month follow-up. The primary aim of the study will be tested with analysis of variance (ANOVA) using the change in OSW score from baseline to 4-weeks (OSW(Baseline )– OSW(4-weeks)) as the dependent variable. The independent variable will be treatment with three levels (lumbo-pelvic manipulation, alternative lumbar manipulation, lumbar mobilization). DISCUSSION: This trial will be the first to investigate the effectiveness of various manual therapy techniques for patients with LBP who satisfy a CPR

Back pain in primary care : aspects on treatment and the possible influence of oral contraceptives

The general objectives of this thesis were to investigate back pain in a primary-care setting, and especially to study the effect of manual treatment on pelvic-joint dysfunction, the effect of sterile-water injections on chronic, myofascial pain and the possible influence of oral contraceptives (OC) on back pain in women in the fertile ages. The effect of a single intervention with manipulation mobilisation was compared with that of massage on pelvic-joint dysfunction with regard to sick-leave, consumption of analgesic, pain and joint mobility. The patients (n=39) formed two groups for treatment and sham treatment, respectively. The outcome as regarded sick-leave and use of analgesics, was significantly lower for the treatment group, while mobility, as measured by Patrick's test and also pain assessments with VAS, did not differ significantly. Sterile water injections sub- and intracutaneously were compared with saline injections given the same way in a randomised, controlled trial on 117 patients with chronic myofascial pain in six different medical centres. A single intervention session was used. Both interventions had a positive effect on pain and mobility, but sterile water was not found to be better than saline with regard to pain relief. In a population study, 1,006 women in the ages 14-44 years, of whom 503 were OC users according to a register of pharmaceuticals used and 503 had not been using OC for the last 5 years, the registers of primary health diagnoses were compared, and a difference in low-back- pain (LBP) diagnoses was found, in that the OC users had a higher prevalence of LBP as a cause of primary care contact than the non-users had. The difference was significant (p<0.05) for 2 of the recorded 5 years. To investigate the possible causes of this association, serum relaxin was measured during the menstrual cycle in 12 healthy women and in 7 women with chronic, posterior,pelvic pain (PPP). Relaxin was also recorded during 1 month of OC use in the healthy women. Relaxin was detected during the menstrual cycle in both groups of women and also during OC use and tended to be higher during OC use. Collagen metabolism markers, the aminoterminal of procollagen type I (PINP), the carboxyterminal telopeptide of type I collagen (ICTP) and the aminoterminal of procollagen type III (PIIINP), were also measured in two groups of non- pregnant women, 20 healthy nulliparous, before and at 3months and 1 year of OC-use and 12 with PPI? complaints, during the normal menstrual cycle and also during one month of OC use. Collagen turnover was diminished during OC use and a shift was also recorded in the anabolic/catabolic hormone balance tending towards an increased catabolism, as estimated by the levels of sexual- hormone-binding globulin (SHBG), insulin growth factor I (IGF-I) and testosterone. In conclusion, the outcome of the treatment trials points to a positive effect of manual treatment on pelvic-joint dysfunction of acute and sub-acute duration, while sterile-water injection treatment could not be recommended for chronic myofascial pain. LBP in women was found to be associated with OC use. Whether the association is causal or not cannot be concluded from this study. However, also serum-relaxin levels and collagen metabolism were influenced by the use of OC s

Relaxin affects the in vivo mechanical properties of some but not all tendons in normally menstruating young females.

Background: Relaxin (hRLX) is a hormone reported to affect collagen synthesis. Its effects are also thought to be modulated by other sex hormones, including oestrogen, which has previously been found to be associated with altering in vivo tendon properties. There is thus a potential for hRLX to impact on collagen, which could result in tendon structural and mechanical properties being modified. Aims: The present study therefore aimed to determine any interaction between hRLX and tendon stiffness, in normally menstruating females (n = 12). Methods: Tendon properties were determined using a combination of dynamometry and B mode ultrasound, whilst serum hRLX levels were established by ELISA. Results: Serum hRLX level was seen to be negatively associated with patellar tendon stiffness (r = -0.56; p0.05), or with any of the two tendons CSA (p>0.05). Conclusion: In young, normally menstruating females, hRLX appears to have a significant effect on the patellar but not the gastrocnemius tendon stiffness. Where it has an affect, this appears to be on the intrinsic properties rather than on the dimensions of said tendon. Future work to elucidate the physiological cause for this selectivity in the impact of relaxin will be key to mapping the impact of the endocrine system on the phenotype of tendinous tissue