[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-pain":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100658884","spinal-manual-therapy-under-sedation-100658884",false,"NCT07858747","Spinal Manual Therapy Under Sedation","Pilot Study on Blinding Spinal Manual Therapy by Sedation - Getting Closer Towards High-quality Investigations of the Efficacy of Manual Therapies","MUS","Inclusion Criteria:\n\n* Signed Informed Consent\n* Chronic (\\>3 months) non-specific LBP and\u002For neck pain (radiating pain included)\n* No experience with MUS\n* Previous successful treatment with conventional spinal manual therapy (without sedation)\n* ≥18 years\n\nExclusion Criteria:\n\n* Previous MUS\n* Previous unsuccessful treatment with conventional spinal manual therapy (without sedation)\n* No experience with conventional spinal manual therapy (without sedation)\n* Recent-onset (\\\u003C1 years) radiculopathy (sensory and\u002For motor loss)\n* Any contraindication to spinal manipulation, e.g., spinal fracture, spinal infection, spinal inflammation, spondylodesis in the spinal region subject to MUS, ruled out by history\n* Diagnosis of osteoporosis\n* Previous non-traumatic fracture\n* Diagnosis of osteopenia\n* Clinical suspicion of osteoporosis\n* Severe systemic disease (\\>ASA II)\n* Obesity (class II) with BMI ≥35 kg\u002Fm2\n* Underweight (BMI \\\u003C18.5 kg\u002Fm2)\n* Patients with an indication for rapid sequence anesthesia (e.g., acid reflux, gastric bypass)\n* Patients with anticipated difficulty in achieving adequate sedation (e.g., substance abuse, increased opioid tolerance)\n* Patients with anticipated difficult airway (e.g. known difficult airway in previous anesthesia, known altered anatomy of the jaw, larynx or trachea, small mouth opening)\n* Pregnancy or breast feeding, ruled out by history\n* Inability to follow the procedures of the study, e.g. due to language problems, dementia","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","Several health care professions use manual therapy techniques (joint manipulation and mobilization, and soft tissue treatment) to successfully treat back and neck pain. However, it is still unknown how manual techniques work. As with any type of treatment, there are at least two possible explanations. First, the treatment might cause physical changes in the body; for manual therapy, these would be changes in the joints, muscles, or other tissues. Second, patients might feel better because they believe the treatment will help. In drug trials, it is relatively easy to determine the extent to which patients' beliefs contribute to treatment effects: patients can be given a dummy pill with no active ingredient (a \"placebo\"). In this way, patients are \"blinded,\" meaning that they do not know whether they received the real drug or not. In manual therapy studies, however, blinding is difficult because patients can feel whether or not they are receiving real treatment. This problem can be overcome by sedating patients: while asleep, patients receive either real hands-on manual therapy or no treatment. Because patients do not know which treatment they received, it becomes possible to determine whether any benefits result from changes in the body or from patients' expectations.\n\nIn this pilot study, 20 participants with low back or neck pain lasting at least three months will be sedated for approximately 15 minutes. Half of them (the \"true group\") will receive manual therapy to the spine. The other half (the \"sham group\") will be sedated for the same length of time but will not receive any treatment. Before and after the intervention, and again at a follow-up visit two weeks later, spinal mobility will be assessed and blood samples will be collected to measure substances known to change after spinal manipulative therapy. At these time points, and again at three and six months, participants will complete questionnaires about their pain, how much the pain limits them, any side effects they notice, which treatment they believe they received, and how they experienced the intervention and the period that followed.\n\nThe purpose of this pilot study is twofold. First, the study will assess whether enough participants can be recruited and retained for the full study duration, and whether they remain unaware of their group allocation. If participants correctly guess which group they were in, this would indicate that they were not truly blinded. Second, preliminary data from the questionnaires, mobility tests, and blood samples will be collected to explore potential differences between the true and sham groups. These results will help in designing a larger follow-up study, which is planned if this pilot study is successful. Such a study could then determine whether manual therapy works through physiological changes in the body, through patient expectations, or through a combination of both. Participants in this pilot study may benefit directly through reduced pain and\u002For improved spinal mobility. More broadly, the knowledge gained from this pilot study may ultimately lead to improved treatments and better clinical outcomes for patients with spinal pain.",[27],"Spinal Pain",[29,30,31,32,33],"Manual therapy","pilot study","Spine","Sedation","Randomized controlled trial","NOT_YET_RECRUITING","2026-10-05",{"date":37,"type":38},"2026-10-08","ACTUAL",{"date":40,"type":21},"2027-01-15",{"date":42,"type":21},"2029-11-01",{"name":44,"class":45},"Schweinhardt Petra","OTHER"]