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Is Hip Range of Motion Relevant in the Treatment of Chronic Low Back Pain?

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Control group
Intervention group
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 focused on measuring Hip Joint, Gluteus Maximus, Manual Therapy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with non-specific low back pain, with a score of more than 2 on the visual analogue scale.
  • Pain with a course of more than 12 weeks, of a chronic nature.

Exclusion Criteria:

  • Patients with neurological signs and symptoms or severe psychiatric illnesses.
  • Subjects with a history of severe trauma, fracture or previous surgery on the lumbar spine or hip.
  • Subjects with a history of musculoskeletal and/or rheumatologic disease.
  • Patients with low back pain attributable to dysmenorrhoea.
  • Pregnant patients.
  • Individuals with fibromyalgia, autoimmune disorders.
  • Subjects with a history of oncological processes.

Sites / Locations

  • Manuel Rojas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control Group. Gluteus maximus strengthening specific program

Intervention group. Specific manual therapy program for hip joint and Gluteus maximus strengthening

Arm Description

Outcomes

Primary Outcome Measures

Changes in 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).

Secondary 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.
Changes in Health related quality of life
Using SF-36. This scale is made up of 36 items divided into 8 sections: 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).
Changes in 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.
Changes in Gluteus Maximus Strength
measured with a wireless digital hand-held dynamometer (microFET ® 2). It has a measurement range of 0-300 lbs (pounds). You can select the unit of measurement: pounds, Newtons or Kilogram-force. The three main actions of the gluteus maximus will be assessed with respect to its action on the hip: abduction, extension and external rotation.
Changes in the Range of Motion of the Hip Joint
measured with an 18 cm universal goniometer. The movements to be evaluated are associated with flexion, extension, internal rotation, external rotation, abduction and adduction to end range without pain, explored passively.

Full Information

First Posted
March 30, 2022
Last Updated
September 6, 2022
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT05328063
Brief Title
Is Hip Range of Motion Relevant in the Treatment of Chronic Low Back Pain?
Official Title
Impact of Manual Therapy on the Coxofemoral Joint in Patients With Chronic Low Back Pain of Non-Specific Origin.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
June 8, 2022 (Actual)
Study Completion Date
July 8, 2022 (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 60 subjects aged between 18 and 35 with non.specific low back pain will be selected and randomized in two interventions. The control group will carry out a specific strengthening program for the gluteus maximus and the experimental group will carry out the same strengthening program in addition to receiving a specific manual therapy program for both hips. The total duration of the treatments will be 8 weeks, with on-treatment evaluations at 4 and 8 weeks, with a follow-up after 1 month. The objective will be to determine the efficacy of manual therapy on the coxofemoral joint together with a protocol of gluteus maximus strengthening exercises in patients with non-specific chronic low back pain, in comparison with the same protocol of gluteus maximus strengthening exercises performed in isolation, in patients with non-specific chronic low back pain.
Detailed Description
Detailed Description has not been entered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Hip Joint, Gluteus Maximus, Manual Therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control Group. Gluteus maximus strengthening specific program
Arm Type
Experimental
Arm Title
Intervention group. Specific manual therapy program for hip joint and Gluteus maximus strengthening
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
All subjects will carry out a gluteus maximus strengthening work out. The exercises should be performed at a frequency of 3 times/week and with a dosage of 3 sets of 8 repetitions. 1-4 Weeks: 1. Bilateral gluteal bridge: Supine decubitus with knees and hips bent and feet supported. To raise the pelvis until the knees are flexed to 90° and then returns to the starting position. 2.Clam shell: Lateral decubitus with knees and hips bent to 45º, working leg placed on top of the other. Separate this knee while feet remain in contact using a medium density Theraband on the distal thighs. Bilateral work. 3. Side-Step: Bipedestation with Knees and hips bent. The exercise then consists of two steps taken in one direction followed by two steps in the opposite direction to return to the starting position. The elastic band shall be placed above the knees. 4-8 Weeks: 1.Unilateral gluteal bridge. 2 Clam shell: hips bents to 60º. 3. Side-Step: placing the elastic band over the ankles
Intervention Type
Other
Intervention Name(s)
Intervention group
Intervention Description
All subjects will receive a specific program of manual therapy on the hip joint. 10 sessions of manual therapy will be applied during 8 weeks, 1 session per week, except the first week when two sessions will be applied. The protocol consists of passive manual joint therapy at low speed on the hip, applying each mobilization in 3 series of 10 repetitions. It also includes muscle stretching, performing 3 series and holding the stretch for 25 seconds. Manual therapy includes: 1. Anteroposterior (AP) and posteroanterior (PA) displacement of the hip. 2. Lateromedial and mediolateral displacement of the hip. 3. Distraction of the long axis/traction of the hip. 4. Lower slip in internal rotation (IR) and external rotation (ER) of the hip. 5. Iliopsoas stretch. 6. Piriformis stretch.To perform the protocol, the patient shall be placed in the supine decubitus position. In addition to the same gluteus maximus strengthening programme used for the control group.
Primary Outcome Measure Information:
Title
Changes in Pain
Description
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).
Time Frame
Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Secondary 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, 4 weeks, 8weeks, 1 month after intervention commencement
Title
Changes in Health related quality of life
Description
Using SF-36. This scale is made up of 36 items divided into 8 sections: 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, 4 weeks, 8weeks, 1 month after intervention commencement
Title
Changes in Depression
Description
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.
Time Frame
Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Title
Changes in Gluteus Maximus Strength
Description
measured with a wireless digital hand-held dynamometer (microFET ® 2). It has a measurement range of 0-300 lbs (pounds). You can select the unit of measurement: pounds, Newtons or Kilogram-force. The three main actions of the gluteus maximus will be assessed with respect to its action on the hip: abduction, extension and external rotation.
Time Frame
Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Title
Changes in the Range of Motion of the Hip Joint
Description
measured with an 18 cm universal goniometer. The movements to be evaluated are associated with flexion, extension, internal rotation, external rotation, abduction and adduction to end range without pain, explored passively.
Time Frame
Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with non-specific low back pain, with a score of more than 2 on the visual analogue scale. Pain with a course of more than 12 weeks, of a chronic nature. Exclusion Criteria: Patients with neurological signs and symptoms or severe psychiatric illnesses. Subjects with a history of severe trauma, fracture or previous surgery on the lumbar spine or hip. Subjects with a history of musculoskeletal and/or rheumatologic disease. Patients with low back pain attributable to dysmenorrhoea. Pregnant patients. Individuals with fibromyalgia, autoimmune disorders. Subjects with a history of oncological processes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Rojas
Organizational Affiliation
University of Alcalá, Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manuel Rojas
City
Madrid
State/Province
Alcalá De Henares
ZIP/Postal Code
28801
Country
Spain

12. IPD Sharing Statement

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Is Hip Range of Motion Relevant in the Treatment of Chronic Low Back Pain?

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