None listed
Conditions
Brief summary
This study is a randomised trial looking at how pressure pain threshold and temporal sensory summation change following lumbar spinal manipulative therapy, by comparing this to a sham treatment. It also aims to look at how pain sensitivity differs between people with and without lower back pain, depending on the severity of lower back pain, and based on how they respond to treatment. We will recruit 80 participants with lower back pain, who will randomly receive either a lumbar or sham manipulation. Pain sensitivity will then be measured at various areas of the body for 30 minutes. Participants will then return for 3 additional visits, where pain sensitivity will be measured again before receiving a real treatment, involve manipulation, mobilisation, and soft tissue therapy as deemed appropriate for that participant. 20 healthy volunteers without lower back pain will also have their pain sensitivity measured, but will not receive treatment.
Interventions
The initial visit will involve randomisation to receive either an active intervention or sham. The active intervention is a single high-velocity low-amplitude lumbar manipulation targeting the L5-S1 facet joint on the participant's most symptomatic side. The participant will be in the side-lying position, with the upper leg bent and lower leg straight. The clinician will contact the target joint with their hand, and stabilise the participant at the shoulder and knee. The clinician will then deliver a rapid and short thrust into the joint into the joint. A “cracking” or “popping” noise may be heard during the SMT. This will take approximately 1 minute to complete, and will be delivered in a private research room, on a chiropractic examination table, by a chiropractor with a minimum of 3 years clinical experience. Several chiropractors will deliver these interventions, and will receive training to standardise techniques and participant interaction, in the form of a single 30-60 minute small group workshop run by a researcher who is also a chiropractor. At each of 3 follow-up visits, the intervention is a pragmatic chiropractic treatment (not randomised) involving a combination of mid and lower back spinal manipulation, spinal mobilisation, soft tissue therapy, education, and advice as appropriate for the individual participant. The specific treatment approach will be determined based on the participant's history and physical examination. The follow-up treatments are expected to take 10-15 minutes, and are intended to replicate an evidence-based private practice chiropractic treatment. These will be delivered by a researcher who is a chiropractor with >3 years clinical experience, and each of the 3 follow-up visits will occur within 4-10 days of the previous visit. Treatment notes will be kept at each follow-up visit, recording symptomatic change, physical examination findings, specific treatments delivered, and advice provided.
Sponsors
Study design
Eligibility
Inclusion criteria
For symptomatic participants: history of LBP in the previous 12 months For healthy participants: no history of LBP in the previous 12 months
Exclusion criteria
1. Are a current chiropractic student or chiropractor (not relevant for healthy participants) 2. Have had spinal manipulation within the previous 6 days 3. Skin condition at pain sensitivity testing site 4. Any absolute or pertinent relative contraindications to mid or lower back manipulation 5. Have active “pinching” of mid or lower back spinal nerves, neurological symptoms, or a neurological condition (e.g. stroke, multiple sclerosis, Parkinson’s syndrome) 6. Have fibromyalgia or chronic widespread pain 7. Have an inflammatory joint condition (e.g. rheumatoid arthritis) 8. Have a bleeding disorder or take anticoagulant medication (e.g. warfarin) [does not include low-dose aspirin] 9. Have had pain-relieving medication, more than 2 standard drinks of alcohol, or recreational drugs in the previous 24 hours