Chronic Low-back PainNCT05328063
Is Hip Range of Motion Relevant in the Treatment of Chronic Low Back Pain?
A study testing Intervention group in people with Chronic Low-back Pain, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 8 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Manual Therapy on the Coxofemoral Joint in Patients With Chronic Low Back Pain of Non-Specific Origin.
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.
Read more
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.
Read the detailed description
Detailed Description has not been entered.
- Conditions
- Chronic Low-back Pain
- Being tested
- Control group, Intervention group
- Keywords
- Hip Joint, Gluteus Maximus, Manual Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group. Gluteus maximus strengthening specific program | Experimental | Not described Receives: Other: Control group |
| Intervention group. Specific manual therapy program for hip joint and Gluteus maximus strengthening | Experimental | Not described Receives: Other: Control group; Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Secondary outcomes (5)
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.
Measured: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
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).
Measured: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
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.
Measured: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
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.
Measured: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
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.
Measured: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start4 Apr 2022
- Primary completion8 Jun 2022
- Study completion8 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Manuel Rojas, Principal investigator, University of Alcalá, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328063
- Sponsor's protocol ID
- CEIM/2022/1/002
- Status last verified
- Mar 2022
- First submitted
- 30 Mar 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Manual Therapy on the Coxofemoral Joint in Patients With Chronic Low Back Pain of Non-Specific Origin.
- ClinicalTrials.gov ID
- NCT05328063
- Acronym / sponsor ID
- CEIM/2022/1/002
- Conditions
- Chronic Low-back Pain
- Keywords
- Hip Joint, Gluteus Maximus, Manual Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 group, Other: Intervention group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control groupAll 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 | Other | Control Group. Gluteus maximus strengthening specific program, Intervention group. Specific manual therapy program for hip joint and Gluteus maximus strengthening |
| Intervention groupAll 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. | Other | Intervention group. Specific manual therapy program for hip joint and Gluteus maximus strengthening |
Primary outcome
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).
5 secondary outcomes
Changes in Disability
Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Changes in Health related quality of life
Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Changes in Depression
Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Changes in Gluteus Maximus Strength
Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Changes in the Range of Motion of the Hip Joint
Time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Rojas principal investigator
University of Alcalá, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Chronic Low-back Pain, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain (time frame: Baseline, 4 weeks, 8weeks, 1 month after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.