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Completed

NCT Number: NCT05328063

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

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.

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Key information

Conditions

Chronic Low-back Pain

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Rojas

Madrid, Alcalá de Henares, 28801, Spain

About this study

Detailed Description has not been entered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

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

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.

Primary outcomes

  1. Changes in Pain

    Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

    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 outcomes

  1. Changes in Disability

    Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

    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.

  2. Changes in Health related quality of life

    Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

    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).

  3. Changes in Depression

    Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

    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.

  4. Changes in Gluteus Maximus Strength

    Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

    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.

  5. Changes in the Range of Motion of the Hip Joint

    Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement

    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.

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

Impact of Manual Therapy on the Coxofemoral Joint in Patients With Chronic Low Back Pain of Non-Specific Origin.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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