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

NCT ID: NCT05328063

Last Updated: 2022-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-04
• Study Completion Date: 2022-07-08

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.

Conditions

Chronic Low-back Pain

Study Design

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

Study Groups

Control Group. Gluteus maximus strengthening specific program

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

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 group

Intervention Type: OTHER

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.

Interventions

Control group

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 group

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 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

Principal Investigators

Manuel Rojas

Role: PRINCIPAL_INVESTIGATOR

University of Alcalá, Madrid, Spain

Locations

Manuel Rojas

Madrid, Alcalá de Henares, Spain

Countries

Spain

Other Identifiers

CEIM/2022/1/002

Identifier Type: -

Identifier Source: org_study_id