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Does Low Back Position Matters in Manual Therapy Treatment

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Posteroanterior mobilization (neutral)
Posteroanterior mobilization (extension)
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Adrián Cabañas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Pressure pain threshold
measured with a Wagner brand Force Dial with a 1 cm2 rubber disc at the end of the device.
Changes in Site of pain
measured with the body pain map
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).
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).
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.
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.
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)
Changes in Medication
The patient will be asked about how many days a week they have needed to take medication

Full Information

First Posted
December 5, 2020
Last Updated
June 9, 2021
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04664348
Brief Title
Does Low Back Position Matters in Manual Therapy Treatment
Official Title
Is the Positioning of the Lumbar Spine Relevant to the Manual Treatment of the Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Adrián Cabañas
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain

12. IPD Sharing Statement

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