Low Back PainNCT03794869
Short-term Effects of Exercise Program Versus Electropuncture in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.
A study testing Percutaneous electrostimulation treatment (EPS) and Exercise program in people with Low Back Pain and Exercise Program, run by Universidad de Almeria at 1 site in Spain.
Trial summary
This study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Low Back Pain, Exercise Program, Electroacupuncture
- What is being tested?
- Percutaneous electrostimulation treatment (EPS) and Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2018to 16 May 2018
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic non-specific low back pain persisting ≥ 3 months.
- Age between 25 and 60 years.
- Not currently receiving physical therapy.
Who cannot join
- Presence of lumbar stenosis.
- Presence of clinical signs of radiculopathy.
- Diagnosis of spondylolisthesis.
- Diagnosis of fibromyalgia.
- Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
- A history of spinal surgery.
- Central or peripheral nervous system disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Exercise Program Versus Electropuncture on Pain, Depression, Range of Motion and Disability, in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.
This study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain.
Read the detailed description
Low back pain has a high prevalence in all European countries, appearing as the main cause of activity limitation in people under 45 years of age. It has got a high recurrence, which decreases the activities of daily life, facilitates the focus of attention to pain and increases the fear of movement, with the consequent muscular atrophy. A serie cases will be conducted comparing a a table of exercises versus electropuncture.
Objective: Evaluate the effectiveness that exists when performing a tratment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture.
Methods: A sample of 12 subjects with chronic low back pain will be assigned to an exercise program or dry electropuncture treatment (EPS), during 4 weeks (2 sessions/week). The measurement variables selected for the study were the followings: Straight Leg Raise, Vasalva, Gaesslen test, algometry (pressure pain threshold), goniometry (measurement of the range of motion), Scale of disability for low back pain of Oswestry, Beck's Depression Inventory (BDI), Visual Analogue Scale (EVA), Mcquade's Test and the Roland-Morrys' Questionnaire, developing a pre-treatment and post-treatment assessment.
- Conditions
- Low Back Pain, Exercise Program, Electroacupuncture
- Being tested
- Percutaneous electrostimulation treatment (EPS), Exercise program
- Keywords
- chronic low back pain, physical therapy, randomized clinical trial, exercise program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous electrostimulation treatment (EPS)Other
Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents.
Exercise programOther
It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Experimental | It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of the core: awareness of breathing, front and side plate abdominal, glute bridge/hip elevations, lift extended leg, pelvic tilt, hamstring stretch, strengthening lower abdominals, cat-camel posture, trunk rotations with flexed knees, rolling in sitting and lumbar extension with hip extensión in prone Receives: Other: Percutaneous electrostimulation treatment (EPS) |
| Percutaneous electrostimulation treatment (EPS) | Active comparator | Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents. Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometry
An instrument for measuring the degree of sensitivity to pain.
Measured: At baseline and immediate post-treatment
Secondary outcomes (6)
Goniometry
Measurement of the range of motion
Measured: At baseline and immediate post-treatment
Beck's Depression Inventory
The state of depression will be determined with the Beck Depression Inventory (BDI), a self-applied 21-item questionnaire that assesses a wide spectrum of depressive symptoms. It focuses on the cognitive components of depression, which represent around 50% of the total questionnaire score.
Measured: At baseline and immediate post-treatment
Visual Analog Scale
Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).
Measured: At baseline and immediate post-treatment
Oswestry Low Back Pain Disability Index.
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points
Measured: At baseline and immediate post-treatment
Roland-Morrys' Questionnaire
This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities
Measured: At baseline and immediate post-treatment
Mcquade Test
It measures the isometric endurance of trunk flexion muscles
Measured: At baseline and immediate post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start15 Apr 2018
- Primary completion16 Apr 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for 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
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adelaida María Castro-Sánchez, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794869
- Sponsor's protocol ID
- UAL-477
- Status last verified
- Jan 2019
- First submitted
- 3 Jan 2019
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.
PubMed 15363431Pérez Guisado J. Contribución al estudio de la lumbalgia inespecífica. Rev Cubana Ortop Traumatol. 2006;20(2).
Hernandez GA, Zamora Salas JD. [Exercise as a treatment for low back pain management]. Rev Salud Publica (Bogota). 2017 Jan-Feb;19(1):123-128. doi: 10.15446/rsap.v19n1.61910. Spanish.
PubMed 30137166Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70.
PubMed 20940644Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.
PubMed 22613238Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
PubMed 26487293Lizier DT, Pérez V, Sakata K. Ejercicios para el tratamiento de la lumbálgia inespecífica. Rev. Bras. Anestesiol. 2012;62(6):842-846.
Mehrparvar AH, Heydari M, Mirmohammadi SJ, Mostaghaci M, Davari MH, Taheri M. Ergonomic intervention, workplace exercises and musculoskeletal complaints: a comparative study. Med J Islam Repub Iran. 2014 Jul 16;28:69. eCollection 2014.
PubMed 25405134Goldby LJ, Moore AP, Doust J, Trew ME. A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder. Spine (Phila Pa 1976). 2006 May 1;31(10):1083-93. doi: 10.1097/01.brs.0000216464.37504.64.
PubMed 16648741Slade SC, Keating JL. Trunk-strengthening exercises for chronic low back pain: a systematic review. J Manipulative Physiol Ther. 2006 Feb;29(2):163-73. doi: 10.1016/j.jmpt.2005.12.011.
PubMed 16461178Slade SC, Keating JL. Unloaded movement facilitation exercise compared to no exercise or alternative therapy on outcomes for people with nonspecific chronic low back pain: a systematic review. J Manipulative Physiol Ther. 2007 May;30(4):301-11. doi: 10.1016/j.jmpt.2007.03.010.
PubMed 17509439Angel Garcia D, Martinez Nicolas I, Saturno Hernandez PJ, Lopez Soriano F. [Clinical approach to chronic lumbar pain: a systematic review of recommendations included in existing practice guidelines]. An Sist Sanit Navar. 2015 Jan-Apr;38(1):117-30. doi: 10.23938/ASSN.0059. Spanish.
PubMed 25963464Barlas P, Ting SL, Chesterton LS, Jones PW, Sim J. Effects of intensity of electroacupuncture upon experimental pain in healthy human volunteers: a randomized, double-blind, placebo-controlled study. Pain. 2006 May;122(1-2):81-9. doi: 10.1016/j.pain.2006.01.012. Epub 2006 Mar 9.
PubMed 16527396Mayor D. Electroacupunture: a practical manual and resource. Churchill Livingstone, 2007.
Hamza MA, Ghoname EA, White PF, Craig WF, Ahmed HE, Gajraj NM, Vakharia AS, Noe CE. Effect of the duration of electrical stimulation on the analgesic response in patients with low back pain. Anesthesiology. 1999 Dec;91(6):1622-7. doi: 10.1097/00000542-199912000-00012.
PubMed 10598602
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Exercise Program Versus Electropuncture on Pain, Depression, Range of Motion and Disability, in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03794869
- Acronym / sponsor ID
- UAL-477
- Conditions
- Low Back Pain, Exercise Program, Electroacupuncture
- Keywords
- chronic low back pain, physical therapy, randomized clinical trial, exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 7 Jan 2019 (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.
This study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain.
Detailed description
Low back pain has a high prevalence in all European countries, appearing as the main cause of activity limitation in people under 45 years of age. It has got a high recurrence, which decreases the activities of daily life, facilitates the focus of attention to pain and increases the fear of movement, with the consequent muscular atrophy. A serie cases will be conducted comparing a a table of exercises versus electropuncture.
Objective: Evaluate the effectiveness that exists when performing a tratment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture.
Methods: A sample of 12 subjects with chronic low back pain will be assigned to an exercise program or dry electropuncture treatment (EPS), during 4 weeks (2 sessions/week). The measurement variables selected for the study were the followings: Straight Leg Raise, Vasalva, Gaesslen test, algometry (pressure pain threshold), goniometry (measurement of the range of motion), Scale of disability for low back pain of Oswestry, Beck's Depression Inventory (BDI), Visual Analogue Scale (EVA), Mcquade's Test and the Roland-Morrys' Questionnaire, developing a pre-treatment and post-treatment assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Experimental | Other: Percutaneous electrostimulation treatment (EPS)It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of the core: awareness of breathing, front and side plate abdominal, glute bridge/hip elevations, lift extended leg, pelvic tilt, hamstring stretch, strengthening lower abdominals, cat-camel posture, trunk rotations with flexed knees, rolling in sitting and lumbar extension with hip extensión in prone |
| Percutaneous electrostimulation treatment (EPS) | Active comparator | Other: Exercise programApply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic non-specific low back pain persisting ≥ 3 months.
- Age between 25 and 60 years.
- Not currently receiving physical therapy.
Key exclusion criteria (7 listed)
- Presence of lumbar stenosis.
- Presence of clinical signs of radiculopathy.
- Diagnosis of spondylolisthesis.
- Diagnosis of fibromyalgia.
- Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
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 |
|---|---|---|
| Percutaneous electrostimulation treatment (EPS)Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents. | Other | Exercise program |
| Exercise programIt will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE. | Other | Percutaneous electrostimulation treatment (EPS) |
Primary outcome
Algometry
Time frame: At baseline and immediate post-treatment
An instrument for measuring the degree of sensitivity to pain.
6 secondary outcomes
Goniometry
Time frame: At baseline and immediate post-treatment
Beck's Depression Inventory
Time frame: At baseline and immediate post-treatment
Visual Analog Scale
Time frame: At baseline and immediate post-treatment
Oswestry Low Back Pain Disability Index.
Time frame: At baseline and immediate post-treatment
Roland-Morrys' Questionnaire
Time frame: At baseline and immediate post-treatment
Mcquade Test
Time frame: At baseline and immediate post-treatment
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 9 Jan 2019.
- Background: PubMed 15363431Haas M, Groupp E, Kraemer DF. Dose-response for chiropractic care of chronic low back pain. Spine J. 2004 Sep-Oct;4(5):574-83. doi: 10.1016/j.spinee.2004.02.008.
- BackgroundPérez Guisado J. Contribución al estudio de la lumbalgia inespecífica. Rev Cubana Ortop Traumatol. 2006;20(2).
- Background: PubMed 30137166Hernandez GA, Zamora Salas JD. [Exercise as a treatment for low back pain management]. Rev Salud Publica (Bogota). 2017 Jan-Feb;19(1):123-128. doi: 10.15446/rsap.v19n1.61910. Spanish.
- Background: PubMed 20940644Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70.
- Background: PubMed 22613238Castro-Sanchez AM, Lara-Palomo IC, Mataran-Penarrocha GA, Fernandez-Sanchez M, Sanchez-Labraca N, Arroyo-Morales M. Kinesio Taping reduces disability and pain slightly in chronic non-specific low back pain: a randomised trial. J Physiother. 2012;58(2):89-95. doi: 10.1016/S1836-9553(12)70088-7.
- Background: PubMed 26487293Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
- BackgroundLizier DT, Pérez V, Sakata K. Ejercicios para el tratamiento de la lumbálgia inespecífica. Rev. Bras. Anestesiol. 2012;62(6):842-846.
- Background: PubMed 25405134Mehrparvar AH, Heydari M, Mirmohammadi SJ, Mostaghaci M, Davari MH, Taheri M. Ergonomic intervention, workplace exercises and musculoskeletal complaints: a comparative study. Med J Islam Repub Iran. 2014 Jul 16;28:69. eCollection 2014.
- Background: PubMed 16648741Goldby LJ, Moore AP, Doust J, Trew ME. A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder. Spine (Phila Pa 1976). 2006 May 1;31(10):1083-93. doi: 10.1097/01.brs.0000216464.37504.64.
- Background: PubMed 16461178Slade SC, Keating JL. Trunk-strengthening exercises for chronic low back pain: a systematic review. J Manipulative Physiol Ther. 2006 Feb;29(2):163-73. doi: 10.1016/j.jmpt.2005.12.011.
- Background: PubMed 17509439Slade SC, Keating JL. Unloaded movement facilitation exercise compared to no exercise or alternative therapy on outcomes for people with nonspecific chronic low back pain: a systematic review. J Manipulative Physiol Ther. 2007 May;30(4):301-11. doi: 10.1016/j.jmpt.2007.03.010.
- Background: PubMed 25963464Angel Garcia D, Martinez Nicolas I, Saturno Hernandez PJ, Lopez Soriano F. [Clinical approach to chronic lumbar pain: a systematic review of recommendations included in existing practice guidelines]. An Sist Sanit Navar. 2015 Jan-Apr;38(1):117-30. doi: 10.23938/ASSN.0059. Spanish.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous electrostimulation treatment (EPS) and Exercise program in people with Low Back Pain and Exercise Program, run by Universidad de Almeria 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 3 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 9 Jan 2019. 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?
Algometry (time frame: At baseline and immediate post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794869, which also lists 25 linked publications.
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 9 Jan 2019.