Trochanteric BursitisNCT05872971
Dry Needling and Lateral Hip Pain (GTPS)
A study testing Dry Needling and Lasertherapy in people with Trochanteric Bursitis, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
Introduction: Greater Trochanter Pain Syndrome (GTPS) includes a number of disorders involving the lateral hip region, including bursitis, gluteal lacerations, and trigger points in the contractile tissue crossing the hip. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Trochanteric Bursitis
- What is being tested?
- Dry Needling and Lasertherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Apr 2023to 3 Dec 2024
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Lateral hip pain (VAS 3) for at least 3 months
- referring pain to palpation of the insertion of the tendon of the middle and maximum gluteus in the major trochanter
- reproduction of symptoms in at least one of the following tests: 1 - FABER test (Flexion, abduction and external hip rotation) ; 2- Resistive External Rotation Test, 3 - Resistive Isometric Abduction Test , 4 - Unipodal Support Test for 30 seconds.
Who cannot join
- surgery on lower limbs or spine in the last 12 months
- symptoms of osteoarthritis or intra-articular disease of the hip (joint block, limited range of motion and difficulty handling socks and clothes)
- infiltration of the hip with corticosteroids in the last 6 months
- have received physical therapy for this condition in the past three months
- participants who need to use anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Christiane Macedo
Londrina, Paraná, 86038-350
Christiane Macedo, +5543991015123, chmacedo@uel.br
About this study
Official title: Dry Needling vs Lasertherapy in Greater Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial
Introduction: Greater Trochanter Pain Syndrome (GTPS) includes a number of disorders involving the lateral hip region, including bursitis, gluteal lacerations, and trigger points in the contractile tissue crossing the hip. As an alternative resource for pain relief, dry needling, known as Dry Needling (DN) is a technique that has been shown to be effective in the treatment of soft tissue injuries and neuromyofascial pain, with positive effects on musculoskeletal conditions. Objective: to compare the administration of ND and laser therapy on the effectiveness of reducing lateral hip pain and improving function in women with GTPS. Materials and methods: The sample will consist of 30 women, aged between 35 and 60, randomized into 2 groups: GND group (n=15) and GLT group (n=15). Participants will complete the sample characterization questionnaire, the numerical pain scale and the VISA Tendinopathy Questionnaire for Greater Trochanteric Pain Syndrome (VISA-G). Subsequently, they will be submitted to evaluation through functional tests sit and stand 30 seconds, Timed up and go test. After the evaluation, they will be submitted to the treatment. The GDN will receive treatment using the technique by a physiotherapist with specific training in NP. The application will be through the deep technique, in the regions of trigger points of muscles of the posterolateral region of the hip with duration of application from 30 to 60 seconds per point, 8 points of application will be standardized, in the region of muscles of the posterolateral region. hip side. The GLT will receive the Laser application by a physiotherapist specialized in traumato-orthopedics. The equipment will be the Infrared Laser (wavelength 904 nm), by punctual technique. Eight application points will be standardized in the muscles region of the posterolateral region of the hip.
Read the detailed description
If a patient is using an anti-inflammatory, guided by the orthopedist, or a physiotherapy treatment protocol, start only 10 days after the end of the same. As participants, they will be instructed to avoid activities that cause pain during the research period. All others selected until the final evaluation will be discouraged. For all groups, the use of analytical medication prescribed by the orthopedist will be allowed, when requested. As the participants will be asked each session about the use of their analog, the data and the dosage that will occur during the study period will be noted. If necessary, how researchers will contact the orthopedist for information and guidance. If a participant needs to use anti-inflammatory medication during a survey, they will be excluded. The analyzes will be carried out by a blind researcher regarding the allocation of the subjects in each group. Participants who have missing data and those who do not attend all treatment sessions will be included in the analysis.
To establish the results, the following variables will be considered:
- Pain intensity: VAS
- Quality of life: VISA-G questionnaire
- Functional assessment: Soon after, the following functional tests will be performed: 30-second Sit to Stand Test (SL30) and the Timed Up and Go Test (TUG).
The Shapiro-Wilk test will be applied to determine the normality of the sample. Student's t test will be used to compare age, weight, height, body mass index (BMI), and the presence of pain when lying on the hip between groups. The two-way ANOVA test (with Bonferroni post-test) will be used to compare the intra-group and intergroup results, if the data are normal, and will be described as mean and standard deviation. Cohen's D test will be performed to calculate the effect size. Linear correlation between variables will be investigated by Pearson's (or Spearman's) correlation test. If there is a linear correlation between any of the potentially confounding variables, analysis of covariance will be performed using the ANCOVA test. Other necessary analyzes may still be included. The level of statistical significance will be set at p ≤ 0.
- Conditions
- Trochanteric Bursitis
- Being tested
- Dry Needling, Lasertherapy
- Keywords
- lateral hip pain, trochanteric bursitis, greater trochanteric gluteal syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingDevice
Dry Needling: The technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN. The application will be through the deep technique, above 10mm deep, the therapist will score trigger points regions of the muscles of the posterolateral region of the hip with application duration of 30 to 60 seconds. Eight points of application will be standardized in the region of the muscles of the posterolateral region of the hip.
LasertherapyDevice
Lasertherapy: The application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics. The equipment will be infrared laser (904 nm), by point technique. Eight points of application will be standardized in the region of muscles of the posterolateral region of the hip. The time, dose and amounts of application points will be guided according to the dosimetry criteria of the World Association for Photobiomodulation Therapy.
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | The technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN. Receives: Device: Dry Needling |
| Lasertherapy | Active comparator | The application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics. Receives: Device: Lasertherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
the intensity of your pain using the Visual Analog Pain Scale (VAS), which scores your current pain with scores between 0 and 10. Zero is no pain and 10 is considered unbearable pain
Measured: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Secondary outcomes (3)
change in hip function
at each assessment, participants will respond to the VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. It consists of eight questions that assess current symptoms with total scores ranging from 0 to 100, with higher scores indicating less pain and better function.
Measured: evaluation before treatment, immediately at the end of treatment and after 12 weeks post treatment
change in lower limb function
In each assessment, participants will perform the Timed Up And Go Test (TUG)
Measured: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
change in lower limb function
In each assessment, participants will perform the 30'' Sit To Stand Test.
Measured: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start24 Apr 2023
- Primary completion3 Jul 2024 (estimated)
- Study completion3 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Trochanteric BursitisStudies 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
- Model description
- This is a randomized blind clinical trial, with a longitudinal characteristic in the area of physiotherapy and orthopedics. The intervention will consist of 6 weeks, 2 times a week, and the variables of interest will be measured in the pre-treatment period, after the first week, after the third week of treatment, after the end of treatment and after that, there will be a follow up of eight and twelve weeks after treatment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Macedo, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872971
- Sponsor's protocol ID
- Dry Needling e quadril
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Shbeeb MI, Matteson EL. Trochanteric bursitis (greater trochanter pain syndrome). Mayo Clin Proc. 1996 Jun;71(6):565-9. doi: 10.4065/71.6.565.
PubMed 8642885Del Buono A, Papalia R, Khanduja V, Denaro V, Maffulli N. Management of the greater trochanteric pain syndrome: a systematic review. Br Med Bull. 2012 Jun;102:115-31. doi: 10.1093/bmb/ldr038. Epub 2011 Sep 4.
PubMed 21893483Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
PubMed 20823359Fearon AM, Ganderton C, Scarvell JM, Smith PN, Neeman T, Nash C, Cook JL. Development and validation of a VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. Man Ther. 2015 Dec;20(6):805-13. doi: 10.1016/j.math.2015.03.009. Epub 2015 Apr 2.
PubMed 25870117Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PubMed 23680877
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling vs Lasertherapy in Greater Trochanteric Pain Syndrome (GTPS): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05872971
- Acronym / sponsor ID
- Dry Needling e quadril
- Conditions
- Trochanteric Bursitis
- Keywords
- lateral hip pain, trochanteric bursitis, greater trochanteric gluteal syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 3 Jul 2024 (estimated)
- Study completion
- 3 Dec 2024 (estimated)
- First posted
- 24 May 2023 (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.
Introduction: Greater Trochanter Pain Syndrome (GTPS) includes a number of disorders involving the lateral hip region, including bursitis, gluteal lacerations, and trigger points in the contractile tissue crossing the hip. As an alternative resource for pain relief, dry needling, known as Dry Needling (DN) is a technique that has been shown to be effective in the treatment of soft tissue injuries and neuromyofascial pain, with positive effects on musculoskeletal conditions. Objective: to compare the administration of ND and laser therapy on the effectiveness of reducing lateral hip pain and improving function in women with GTPS. Materials and methods: The sample will consist of 30 women, aged between 35 and 60, randomized into 2 groups: GND group (n=15) and GLT group (n=15). Participants will complete the sample characterization questionnaire, the numerical pain scale and the VISA Tendinopathy Questionnaire for Greater Trochanteric Pain Syndrome (VISA-G). Subsequently, they will be submitted to evaluation through functional tests sit and stand 30 seconds, Timed up and go test. After the evaluation, they will be submitted to the treatment. The GDN will receive treatment using the technique by a physiotherapist with specific training in NP. The application will be through the deep technique, in the regions of trigger points of muscles of the posterolateral region of the hip with duration of application from 30 to 60 seconds per point, 8 points of application will be standardized, in the region of muscles of the posterolateral region. hip side. The GLT will receive the Laser application by a physiotherapist specialized in traumato-orthopedics. The equipment will be the Infrared Laser (wavelength 904 nm), by punctual technique. Eight application points will be standardized in the muscles region of the posterolateral region of the hip.
Detailed description
If a patient is using an anti-inflammatory, guided by the orthopedist, or a physiotherapy treatment protocol, start only 10 days after the end of the same. As participants, they will be instructed to avoid activities that cause pain during the research period. All others selected until the final evaluation will be discouraged. For all groups, the use of analytical medication prescribed by the orthopedist will be allowed, when requested. As the participants will be asked each session about the use of their analog, the data and the dosage that will occur during the study period will be noted. If necessary, how researchers will contact the orthopedist for information and guidance. If a participant needs to use anti-inflammatory medication during a survey, they will be excluded. The analyzes will be carried out by a blind researcher regarding the allocation of the subjects in each group. Participants who have missing data and those who do not attend all treatment sessions will be included in the analysis.
To establish the results, the following variables will be considered:
- Pain intensity: VAS
- Quality of life: VISA-G questionnaire
- Functional assessment: Soon after, the following functional tests will be performed: 30-second Sit to Stand Test (SL30) and the Timed Up and Go Test (TUG).
The Shapiro-Wilk test will be applied to determine the normality of the sample. Student's t test will be used to compare age, weight, height, body mass index (BMI), and the presence of pain when lying on the hip between groups. The two-way ANOVA test (with Bonferroni post-test) will be used to compare the intra-group and intergroup results, if the data are normal, and will be described as mean and standard deviation. Cohen's D test will be performed to calculate the effect size. Linear correlation between variables will be investigated by Pearson's (or Spearman's) correlation test. If there is a linear correlation between any of the potentially confounding variables, analysis of covariance will be performed using the ANCOVA test. Other necessary analyzes may still be included. The level of statistical significance will be set at p ≤ 0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized blind clinical trial, with a longitudinal characteristic in the area of physiotherapy and orthopedics. The intervention will consist of 6 weeks, 2 times a week, and the variables of interest will be measured in the pre-treatment period, after the first week, after the third week of treatment, after the end of treatment and after that, there will be a follow up of eight and twelve weeks after treatment.
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Device: Dry NeedlingThe technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN. |
| Lasertherapy | Active comparator | Device: LasertherapyThe application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Lateral hip pain (VAS 3) for at least 3 months
- referring pain to palpation of the insertion of the tendon of the middle and maximum gluteus in the major trochanter
- reproduction of symptoms in at least one of the following tests: 1 - FABER test (Flexion, abduction and external hip rotation) ; 2- Resistive External Rotation Test, 3 - Resistive Isometric Abduction Test , 4 - Unipodal Support Test for 30 seconds.
Key exclusion criteria (5 listed)
- surgery on lower limbs or spine in the last 12 months
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 |
|---|---|---|
| Dry NeedlingDry Needling: The technique will be used by a physiotherapist experienced in orthopedic conditions and with specific training in DN. The application will be through the deep technique, above 10mm deep, the therapist will score trigger points regions of the muscles of the posterolateral region of the hip with application duration of 30 to 60 seconds. Eight points of application will be standardized in the region of the muscles of the posterolateral region of the hip. | Device | Dry Needling |
| LasertherapyLasertherapy: The application of the Laser will be performed by a physiotherapist specialized in traumato-orthopedics. The equipment will be infrared laser (904 nm), by point technique. Eight points of application will be standardized in the region of muscles of the posterolateral region of the hip. The time, dose and amounts of application points will be guided according to the dosimetry criteria of the World Association for Photobiomodulation Therapy. | Device | Lasertherapy |
Primary outcome
change in pain intensity
Time frame: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
the intensity of your pain using the Visual Analog Pain Scale (VAS), which scores your current pain with scores between 0 and 10. Zero is no pain and 10 is considered unbearable pain
3 secondary outcomes
change in hip function
Time frame: evaluation before treatment, immediately at the end of treatment and after 12 weeks post treatment
change in lower limb function
Time frame: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
change in lower limb function
Time frame: evaluation before treatment, immediately at the end of treatment and 12 weeks post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 8642885Shbeeb MI, Matteson EL. Trochanteric bursitis (greater trochanter pain syndrome). Mayo Clin Proc. 1996 Jun;71(6):565-9. doi: 10.4065/71.6.565.
- Background: PubMed 21893483Del Buono A, Papalia R, Khanduja V, Denaro V, Maffulli N. Management of the greater trochanteric pain syndrome: a systematic review. Br Med Bull. 2012 Jun;102:115-31. doi: 10.1093/bmb/ldr038. Epub 2011 Sep 4.
- Background: PubMed 20823359Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- Background: PubMed 25870117Fearon AM, Ganderton C, Scarvell JM, Smith PN, Neeman T, Nash C, Cook JL. Development and validation of a VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. Man Ther. 2015 Dec;20(6):805-13. doi: 10.1016/j.math.2015.03.009. Epub 2015 Apr 2.
- Background: PubMed 23680877Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Lasertherapy in people with Trochanteric Bursitis, run by Universidade Estadual de Londrina at 1 site in Brazil.
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 5 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: status not confirmed, as of the sponsor's last update on 24 May 2023. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain intensity (time frame: evaluation before treatment, immediately at the end of treatment and 12 weeks 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 NCT05872971, which also lists 5 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 24 May 2023.