Efficacy of Mobilization With Movement on Conditioned Pain Modulation in Chronic Low Back Pain Patients
- Conditions
- Chronic Low-back Pain
- Interventions
- Biological: Sham mobilization with movementBiological: Mobilization with movement
- Registration Number
- NCT06078033
- Lead Sponsor
- Eleuterio Atanasio Sánchez Romero
- Brief Summary
Patients with chronic low back pain may have altered endogenous mechanisms, which can be evaluated with conditioned modulation paradigms. Mobilization with movement has demonstrated improvements in endogenous analgesic mechanisms in conditions such as knee osteoarthritis or lateral epicondylalgia. However, its effects have not yet been studied in patients with chronic low back pain. The objective of this randomized clinical trial is to evaluate the efficacy of mobilization with movement compared to placebo on endogenous mechanisms in patients with chronic low back pain.
- Detailed Description
Low back pain is the leading cause of disability worldwide, and chronic low back pain (CLBP) has a prevalence of 2-25%, 80% of which are classified as non-specific low back pain because the causal factors have not yet been determined. Although different mechanisms can be attributed to the chronification of pain, a frequent denominator is the amplification of nociceptive transmission or decreased inhibition of nociceptive stimuli in the peripheral and/or central nervous system.
To assess inhibitory pathways, conditioned pain modulation (CPM) paradigms are commonly used in humans. They are based on the idea that a noxious stimulus applied to one part of the body can inhibit pain elsewhere by activating the descending inhibitory system.
When CPM is evaluated in patients with chronic low back pain, contradictory results are found, with studies reporting an alteration of pain modulation mechanisms and others not.
Different studies found that manual therapy can improve CPM compared to sham in patients with chronic musculoskeletal pain, such as lateral epicondylalgia or knee osteoarthritis. However, its effects in patients with chronic low back pain have not yet been studied.
Therefore, the aim of this study was to investigate the effect of mobilization with motion on CPM in patients with chronic musculoskeletal pain.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- Adults with chronic low back pain (>3 months of pain duration)
- 2 or more on a scale of 0 to 10.
- Radiculopathy
- Neurological signs, symptoms, or deficit
- Rheumatic or autoimmune disease
- Cutaneous disease
- History of fracture or spinal surgery
- Pregnancy
- Neuropathic pain
- Active cancer
- Spondylolysis/Spondylolisthesis
- Mild/Severe cognitive impairment which interferes with outcomes measurement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control: Sham mobilization with movement Sham mobilization with movement Patients allocated to sham group received same evaluation and treatment process. However, only manual contact was performed over the spinous process of the targeted vertebra, without the sustained glide and without applying any force. Three sets of 10 repetitions were performed, with 1-2 minutes rest between sets. Intervention: Mobilization with movement (MWM) Mobilization with movement The MWM technique was performed by asking patients to perform their painful movement (flexion, extension...). If pain was not reproduced, a combination of movements (flexion + rotation...) was performed. The most painful vertebral level was also evaluated with passive accessory vertebral movements. Then, with the patient in a seated position on a stretcher with the feet supported and a belt around the waist, the therapist performed a sustained glide over the targeted vertebra (spinous process) with the force and direction that relieved pain to the lowest level and asked the patient to perform his previous painful movement, as described by Mulligan. Three sets of 10 repetitions were performed, with 1-2 minutes rest between sets.
- Primary Outcome Measures
Name Time Method Conditioned pain modulation 30 minutes Conditioned pain modulation of low back, measured on interspace between L5 and S1. Pressure pain threshold (PPT) was used as test stimulus while ischemic pain (using cuff) was used as conditioning stimulus. CPM effect were calculated as the differences between the PPT values with and without the conditioning stimulus.
- Secondary Outcome Measures
Name Time Method Body Chart Baseline Widespread pain was measured with body chart
Anxiety Baseline Anxiety was measured with Spanish version of State-trait Anxiety Inventory (STAI). Scores of 20-37 indicate no or low anxiety; 38-44 moderate anxiety; 45-80 high anxiety.
Depression Baseline Depressive symptoms were measured with Spanish version of Beck Inventory II. 0-13 normal scores; 14-19 mild; 20-28 moderate; 29-63 severe depression.
Pressure pain threshold 30 minutes Pressure pain thresholds (PPT), measured on interspace between L5 and S1. PPT were measured with an algometer placed and applied perpendicular to the skin. Pressure was gradually increased at a rate of 1kg/sec over the targeted location until patient indicated verbally that the sensation became painful. Measurements were taken two times at the location with 30 seconds rest interval between each measurement. The mean of the two measurements for targeted location was calculated for statistical analysis.
Kinesiophobia Baseline Kinesiophobia was measured with Spanish version of Tampa Scale of Kinesiophobia. Higher scores denotes greater fear of experiencing pain while moving.
Disability Baseline Low back pain associated disability was measured with Spanish version of Roland-Morris Disability Questionnaire. Higher scores denotes greater pain-associated disability.
Quality of life (QoL) Baseline QoL was measured with Spanish version of EuroQol 5-Dimensions. Quality of life visual analogue scale consist of a scale from 0 (worse quality of life) to 100 (best quality of life). Additionally, quality of life index may be summarised by a series of five sentences, one for each dimension and stating the level within that dimension; or a label consisting of five ordinal numbers, one for each dimension (by convention, in the order these appear in the questionnaire), defining the severity level, where 1 means no problems.
Trial Locations
- Locations (1)
Universidad Europea de Madrid
🇪🇸Villaviciosa De Odón, Madrid, Spain