Does Low Back Position Matters in Manual Therapy Treatment
- Conditions
- Chronic Low-back Pain
- Interventions
- Other: Posteroanterior mobilization (extension)Other: Posteroanterior mobilization (neutral)
- Registration Number
- NCT04664348
- Lead Sponsor
- University of Jaén
- Brief Summary
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 46 subjects of legal age with non-specific chronic low back pain will be selected and randomized into two interventions.
The first group will receive lumbar posteroanterior mobilizations with the lumbar spine in extension and the second group will receive lumbar mobilizations with neutral position of the spine. Both groups will also receive a home exercise program for the lumbar spine.
The total duration of the treatments will be 6 weeks, with pre-treatment, at 3 weeks of the treatment, post-treatment evaluations at 6 weeks, with a follow-up after 1 month and with a follow-up after 3 months.
The objective will be to evaluate which of the two interventions is more effective in addressing disability variables (main variable), pressure pain threshold, pain location, pain intensity, quality of life, quality of sleep, depression and kinesiophobia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention
- lumbar pain related to infectious diseases
- fractures
- oncological processes
- women in gestation period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine) Posteroanterior mobilization (extension) - Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning) Posteroanterior mobilization (neutral) -
- Primary Outcome Measures
Name Time Method Changes in Disability Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement measured with the Oswestry Low Back Pain Disability Questionnaire. The interpretation of the scores of this scale varies from 0% to 100%.
0% to 20%: minimal disability: The patient can cope with most living activities.
21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
- Secondary Outcome Measures
Name Time Method Pain measured with visual analogic scale Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement A straight horizontal line of fixed length, usually 100 mm is drawn. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best).
Kinesiophobia measured with the TAMPA scale of kinesiophobia Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement The total score ranges between 17 and 68. A high value on the TAMPA scale of kinesiophobia indicates a high degree of kinesiophobia.
Cutoff score developed by Vlaeyen:
* score of 37 or over is considered as high
* scores below 37 is considered as low)Changes in Pressure pain threshold Baseline, 3 weeks and 6 weeks after intervention commencement measured with a Wagner brand Force Dial with a 1 cm2 rubber disc at the end of the device.
Changes in Medication Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement The patient will be asked about how many days a week they have needed to take medication
Health measured with the short form health survey version II Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement It consists of 12 items from the 8 dimensions of the short form health survey 36: Physical Function, Function Social, Physical role, Emotional role, Mental health, Vitality, Body pain , General Health. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale that ranges from 0 (the worst state of health for that dimension) to 100 (the best state of health).
Quality of sleep measured with the Pittsburgh Sleep Quality Index Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Changes in Site of pain Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement measured with the body pain map
Depression measured with Beck's Depression Inventory Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Higher total scores indicate more severe depressive symptoms.
Trial Locations
- Locations (1)
Adrián Cabañas
🇪🇸Alcalá De Henares, Madrid, Spain