Clinical trial NCT05328063: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Hip Joint
Gluteus Maximus
Manual Therapy
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Pain
timeFrame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Secondary outcomes:
measure: Changes in Disability
timeFrame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
measure: Changes in Health related quality of life
timeFrame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
measure: Changes in Depression
timeFrame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
measure: Changes in Gluteus Maximus Strength
timeFrame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
measure: Changes in the Range of Motion of the Hip Joint
timeFrame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Manuel Rojas
state: Alcalá De Henares
Study officials:
affiliation: University of Alcalá, Madrid, Spain
name: Manuel Rojas
role: PRINCIPAL_INVESTIGATOR
References: