NCT05328063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
Last Updated

September 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 30, 2022

Last Update Submit

September 6, 2022

Conditions

Chronic Low-back Pain

Keywords

Hip JointGluteus MaximusManual Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

Secondary Outcomes (5)

  • Changes in Disability

    Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

  • Changes in Health related quality of life

    Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

  • Changes in Depression

    Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

  • Changes in Gluteus Maximus Strength

    Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

  • Changes in the Range of Motion of the Hip Joint

    Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

Study Arms (2)

Control Group. Gluteus maximus strengthening specific program

EXPERIMENTAL
Other: Control group

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

EXPERIMENTAL
Other: Control groupOther: Intervention group

Interventions

Control groupOTHER

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

Control Group. Gluteus maximus strengthening specific programIntervention group. Specific manual therapy program for hip joint and Gluteus maximus strengthening
Intervention groupOTHER

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

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuel Rojas

Madrid, Alcalá de Henares, 28801, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Manuel Rojas

    University of Alcalá, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 14, 2022

Study Start

April 4, 2022

Primary Completion

June 8, 2022

Study Completion

July 8, 2022

Last Updated

September 8, 2022

Record last verified: 2022-03

Locations

ES(1)