Does Low Back Position Matters in Manual Therapy Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Posteroanterior mobilization (extension); Other: Posteroanterior mobilization (neutral)

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28801
      • Adrián Cabañas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine)	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.
Experimental: Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in Site of pain	measured with the body pain map	Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEIM/HU/2020/42

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No