Does Low Back Position Matters in Manual Therapy Treatment

NCT ID: NCT04664348

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2021-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Posteroanterior mobilization (extension)

Intervention Type: 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 (lumbar spine in neutral positioning)

Group Type: EXPERIMENTAL

Posteroanterior mobilization (neutral)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Alexander Achalandabaso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Adrián Cabañas

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

CEIM/HU/2020/42

Identifier Type: -

Identifier Source: org_study_id