Does Low Back Position Matters in Manual Therapy Treatment

NCT04664348 | Completed

• 1 other identifier: CEIM/HU/2020/42
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes in Pressure pain threshold

  Baseline, 3 weeks and 6 weeks after intervention commencement

• Changes in Site of pain

  Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement

• Pain measured with visual analogic scale

  Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement

• Health measured with the short form health survey version II

  Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement

• Quality of sleep measured with the Pittsburgh Sleep Quality Index

  Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement

Study Arms (2)

Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine)

EXPERIMENTAL

Other: Posteroanterior mobilization (extension)

Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning)

EXPERIMENTAL

Other: Posteroanterior mobilization (neutral)

Interventions

Posteroanterior mobilization (neutral) OTHER

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.

Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning)

Posteroanterior mobilization (extension) OTHER

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.

Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• lumbar pain related to infectious diseases
• fractures
• oncological processes
• women in gestation period.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Adrián Cabañas

Alcalá de Henares, Madrid, 28801, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: December 9, 2020
• Primary Completion: January 31, 2021
• Study Completion: April 30, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

ES (1)