Does Low Back Position Matters in Manual Therapy Treatment

Chronic Low-back Pain Clinical Trial

Official title:

Is the Positioning of the Lumbar Spine Relevant to the Manual Treatment of the Chronic Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664348
• Other study ID #: CEIM/HU/2020/42
• Status: Completed
• Phase: N/A
• Start date: December 9, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 30, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention

Exclusion Criteria:

• lumbar pain related to infectious diseases

• fractures

• oncological processes

• women in gestation period.

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Posteroanterior mobilization (neutral)
Positioning of the patient: Prone position with the lumbar area uncovered. Positioning of the therapist: Stand to one side of the table at the pelvis of the patient. Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain. Both groups: The patient will be provided with a list of exercises focused on improving resistance to mechanical load in the lumbar region. The completion of the exercise will be in the 6 weeks of the duration of the treatment.
• Posteroanterior mobilization (extension)
Positioning of the patient: Prone position with the lumbar area uncovered. The head of the stretcher will be raised upwards, placing progressively to extend the lumbar region, until the patient communicates the reproduction of its symptoms. Positioning of the therapist: Stand to one side of the table at the pelvis of the patient. Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain.

Locations

Country	Name	City	State
Spain	Adrián Cabañas	Alcalá De Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Disability	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.	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Changes in Pressure pain threshold	measured with a Wagner brand Force Dial with a 1 cm2 rubber disc at the end of the device.	Baseline, 3 weeks and 6 weeks after intervention commencement
Secondary	Changes in Site of pain	measured with the body pain map	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Pain measured with visual analogic scale	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).	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Health measured with the short form health survey version II	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).	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Quality of sleep measured with the Pittsburgh Sleep Quality Index	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.	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Depression measured with Beck's Depression Inventory	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.	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Kinesiophobia measured with the TAMPA scale of kinesiophobia	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)	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary	Changes in Medication	The patient will be asked about how many days a week they have needed to take medication	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement