Rotator Cuff TendinitisNCT03675399

Effect of Isometric Exercise on Pain Perception in Rotator Cuff Related Shoulder Pain

A study testing Supra-threshold isometric exercise and Infra-threshold isometric exercise in people with Rotator Cuff Tendinitis, run by University of Valencia at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rotator Cuff Tendinitis
What is being tested?: Supra-threshold isometric exercise and Infra-threshold isometric exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 2 sitesSpain
Study dates: 1 Jun 2019to 15 Apr 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

aged 18-80 years (likelihood of patients > 80 having degenerative changes in the shoulder is increased)
pain localised to the proximal anterolateral shoulder region
positive for pain on at least one of the following three impingement tests: Hawkins-Kennedy, Neer's, Jobe's
positive for pain on resisted external rotation and/or abduction.

Who cannot join

shoulder surgery within last 6 months
reasons to suspect systemic pathology including inflammatory disorders, cervical repeated movement testing affects shoulder pain and/or range of movement, passive external rotation deficit greater (less than 30º or a range of motion reduction of 50% or more as compared to the contralateral side), upper limb tension test A for cervical radiculopathy
atraumatic degenerative rotator cuff tear based on the cluster of clinical tests (painful arc, drop arm test, and marked weakness into ER all three positive)

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Mercè Balasch i Bernat
Valencia, Valencia, 46021
Mercè Balasch i Bernat
Valencia, 46021

Other trials in Spain

About this study

Official title: Effect of Isometric Exercise on Pain Perception in Subjects With Rotator Cuff Related Shoulder Pain

The aim of this study is to compare the immediate effects of an acute bout of isometric exercise of the shoulder external rotator muscles above and below pain threshold on pain intensity, pain threshold, conditioned pain modulation and pain free force in external rotation. To evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and after and 45 minutes after each experimental condition.

Read the detailed description

It will consist of a randomized three-treatment parallel-design study. The sample will consist of subjects with rotator cuff related shoulder pain (RCRSP). Once the sample is selected, subjects will participate in three experimental sessions, which will occur in a randomized order: two exercise sessions (supra-threshold and infra-threshold isometric exercise) and one control session. In the first session, information regarding clinical and demographical aspects will be collected. A washout period of approximately 48 hours will separate each of the experimental sessions.

To evaluate the results of the exercise, the subjects will be assessed at pre-intervention, immediately post-intervention and 45 minutes after each experimental condition. Pain intensity, Pressure Pain Thresholds (PPT), Conditioned Pain Modulation (CPM), maximal voluntary isometric contraction (MVIC) and pain free isometric strength (PFIS) will be measured.

Conditions: Rotator Cuff Tendinitis
Being tested: Supra-threshold isometric exercise, Infra-threshold isometric exercise
Keywords: isometric exercise, rotator cuff, pain threshold
Medical subject headings: Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Supra-threshold isometric exerciseOther
The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).
Infra-threshold isometric exerciseOther
The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).

Study groups in NCT03675399
Study group	Role	What they receive
Supra-threshold isometric exercise	Experimental	Participants will perform 10 isometric external rotation supra-threshold contractions of the affected shoulder, each held for 15 seconds, with resting intervals of 15 seconds between contractions. Receives: Other: Supra-threshold isometric exercise
Infra-threshold isometric exercise	Experimental	Participants will perform 10 isometric external rotation infra-threshold contractions of the affected shoulder, each held for 15 seconds, with resting intervals of 15 seconds between contractions. Receives: Other: Infra-threshold isometric exercise
Control	No intervention	Participants will remain resting.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Measured: Baseline
Pain intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Measured: Immediately post-intervention
Pain intensity
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Lower values represent a better outcome (less pain).
Measured: 45 minutes post-intervention

Secondary outcomes (12)

Pressure Pain Thresholds (PPT)
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. quadriceps. Higher values represent a better outcome.
Measured: Baseline, immediately post-intervention and 45 minutes post-intervention
Pressure Pain Thresholds (PPT)
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. quadriceps. Higher values represent a better outcome.
Measured: Immediately post-intervention
Pressure Pain Thresholds (PPT)
PPTs will be recorded using an electronic algometer at the ipsilateral m. infraspinatus, the contralateral resting m. infraspinatus and the contralateral resting m. quadriceps. Higher values represent a better outcome.
Measured: 45 minutes post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Measured: Baseline
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Measured: Immediately post-intervention
Conditioned pain modulation (CPM)
CPM will be tested using the upper extremity submaximal effort tourniquet test.
Measured: 45 minutes post-intervention
Maximal voluntary isometric contraction (MVIC)
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Measured: Baseline
Maximal voluntary isometric contraction (MVIC)
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Measured: Immediately post-intervention and 45 minutes post-intervention
Maximal voluntary isometric contraction (MVIC)
MVIC will be measured at both m. infraspinatus and m. quadriceps of the non-affected side using a digital force gauge.
Measured: 45 minutes post-intervention
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Measured: Baseline
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Measured: Immediately post-intervention
Pain free isometric strength/threshold (PFIS)
PFIS will be assessed at m. infraspinatus of the affected shoulder
Measured: 45 minutes post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201915 Apr 2021

First posted18 Sep 2018
Study start1 Jun 2019
Primary completion15 Oct 2020
Study completion15 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Rotator Cuff TendinitisStudies of the same condition, open and under way.
More trials run by University of ValenciaThe sponsor's other registered studies.
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: Investigator
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03675399
Sponsor's protocol ID: H1528701290644
Status last verified: Apr 2021
First submitted: 13 Sep 2018
Last updated: 30 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
PubMed 15163107
Watts AR, Williams B, Kim SW, Bramwell DC, Krishnan J. Shoulder impingement syndrome: a systematic review of clinical trial participant selection criteria. Shoulder Elbow. 2017 Jan;9(1):31-41. doi: 10.1177/1758573216663201. Epub 2016 Aug 20.
PubMed 28572848
Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
PubMed 22581193
Luime JJ, Koes BW, Miedem HS, Verhaar JA, Burdorf A. High incidence and recurrence of shoulder and neck pain in nursing home employees was demonstrated during a 2-year follow-up. J Clin Epidemiol. 2005 Apr;58(4):407-13. doi: 10.1016/j.jclinepi.2004.01.022.
PubMed 15862727
Lewis J. Rotator cuff related shoulder pain: Assessment, management and uncertainties. Man Ther. 2016 Jun;23:57-68. doi: 10.1016/j.math.2016.03.009. Epub 2016 Mar 26.
PubMed 27083390
Littlewood C, Malliaras P, Chance-Larsen K. Therapeutic exercise for rotator cuff tendinopathy: a systematic review of contextual factors and prescription parameters. Int J Rehabil Res. 2015 Jun;38(2):95-106. doi: 10.1097/MRR.0000000000000113.
PubMed 25715230
Littlewood C, Ashton J, Chance-Larsen K, May S, Sturrock B. Exercise for rotator cuff tendinopathy: a systematic review. Physiotherapy. 2012 Jun;98(2):101-9. doi: 10.1016/j.physio.2011.08.002. Epub 2011 Oct 5.
PubMed 22507359
Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, Selfe J, Logan P. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(23):1679-1687. doi: 10.1136/bjsports-2016-097383. Epub 2017 Jun 8.
PubMed 28596288
Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
PubMed 22349588
Littlewood C, Bateman M, Brown K, Bury J, Mawson S, May S, Walters SJ. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin Rehabil. 2016 Jul;30(7):686-96. doi: 10.1177/0269215515593784. Epub 2015 Jul 9.
PubMed 26160149
Coombes BK, Wiebusch M, Heales L, Stephenson A, Vicenzino B. Isometric Exercise Above but not Below an Individual's Pain Threshold Influences Pain Perception in People With Lateral Epicondylalgia. Clin J Pain. 2016 Dec;32(12):1069-1075. doi: 10.1097/AJP.0000000000000365.
PubMed 26889612
Naugle KM, Fillingim RB, Riley JL 3rd. A meta-analytic review of the hypoalgesic effects of exercise. J Pain. 2012 Dec;13(12):1139-50. doi: 10.1016/j.jpain.2012.09.006. Epub 2012 Nov 8.
PubMed 23141188
Rio E, Kidgell D, Purdam C, Gaida J, Moseley GL, Pearce AJ, Cook J. Isometric exercise induces analgesia and reduces inhibition in patellar tendinopathy. Br J Sports Med. 2015 Oct;49(19):1277-83. doi: 10.1136/bjsports-2014-094386. Epub 2015 May 15.
PubMed 25979840
Balasch-Bernat M, Lluch E, Vaegter HB, Duenas L. Should Exercises be Painful or not? Effects on Clinical and Experimental Pain in Individuals with Shoulder Pain. J Pain. 2021 Oct;22(10):1246-1255. doi: 10.1016/j.jpain.2021.03.153. Epub 2021 Apr 20.
PubMed 33887445

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Shoulder Tendinopathy, Shoulder Tendinitis
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RecruitingObservational study
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
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All Rotator Cuff Tendinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Isometric Exercise on Pain Perception in Subjects With Rotator Cuff Related Shoulder Pain
ClinicalTrials.gov ID: NCT03675399
Acronym / sponsor ID: H1528701290644
Conditions: Rotator Cuff Tendinitis
Keywords: isometric exercise, rotator cuff, pain threshold
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: University of ValenciaUniversity, hospital or other
Study start: 1 Jun 2019 (actual)
Primary completion: 15 Oct 2020 (actual)
Study completion: 15 Apr 2021 (actual)
First posted: 18 Sep 2018 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Supra-threshold isometric exercise	Experimental	Other: Supra-threshold isometric exerciseParticipants will perform 10 isometric external rotation supra-threshold contractions of the affected shoulder, each held for 15 seconds, with resting intervals of 15 seconds between contractions.
Infra-threshold isometric exercise	Experimental	Other: Infra-threshold isometric exerciseParticipants will perform 10 isometric external rotation infra-threshold contractions of the affected shoulder, each held for 15 seconds, with resting intervals of 15 seconds between contractions.
Control	No intervention	–Participants will remain resting.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

aged 18-80 years (likelihood of patients > 80 having degenerative changes in the shoulder is increased)
pain localised to the proximal anterolateral shoulder region
positive for pain on at least one of the following three impingement tests: Hawkins-Kennedy, Neer's, Jobe's
positive for pain on resisted external rotation and/or abduction.

Key exclusion criteria (3 listed)

shoulder surgery within last 6 months
reasons to suspect systemic pathology including inflammatory disorders, cervical repeated movement testing affects shoulder pain and/or range of movement, passive external rotation deficit greater (less than 30º or a range of motion reduction of 50% or more as compared to the contralateral side), upper limb tension test A for cervical radiculopathy
atraumatic degenerative rotator cuff tear based on the cluster of clinical tests (painful arc, drop arm test, and marked weakness into ER all three positive)

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
Supra-threshold isometric exerciseThe supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).	Other	Supra-threshold isometric exercise
Infra-threshold isometric exerciseThe infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).	Other	Infra-threshold isometric exercise

Primary outcome

Pain intensity
Time frame: Baseline
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Pain intensity
Time frame: Immediately post-intervention
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Higher values represent a better outcome (less pain).
Pain intensity
Time frame: 45 minutes post-intervention
Shoulder pain intensity reported by the patient will be assessed using a 100-mm visual analogue scale (VAS, 0-100, 0=minimum score, 100=maximum score). Lower values represent a better outcome (less pain).

12 secondary outcomes

Pressure Pain Thresholds (PPT)
Time frame: Baseline, immediately post-intervention and 45 minutes post-intervention
Pressure Pain Thresholds (PPT)
Time frame: Immediately post-intervention
Pressure Pain Thresholds (PPT)
Time frame: 45 minutes post-intervention
Conditioned pain modulation (CPM)
Time frame: Baseline
Conditioned pain modulation (CPM)
Time frame: Immediately post-intervention
Conditioned pain modulation (CPM)
Time frame: 45 minutes post-intervention
Maximal voluntary isometric contraction (MVIC)
Time frame: Baseline
Maximal voluntary isometric contraction (MVIC)
Time frame: Immediately post-intervention and 45 minutes post-intervention
Maximal voluntary isometric contraction (MVIC)
Time frame: 45 minutes post-intervention
Pain free isometric strength/threshold (PFIS)
Time frame: Baseline
Pain free isometric strength/threshold (PFIS)
Time frame: Immediately post-intervention
Pain free isometric strength/threshold (PFIS)
Time frame: 45 minutes post-intervention

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 30 Apr 2021.
Background: PubMed 15163107Luime JJ, Koes BW, Hendriksen IJ, Burdorf A, Verhagen AP, Miedema HS, Verhaar JA. Prevalence and incidence of shoulder pain in the general population; a systematic review. Scand J Rheumatol. 2004;33(2):73-81. doi: 10.1080/03009740310004667.
Background: PubMed 28572848Watts AR, Williams B, Kim SW, Bramwell DC, Krishnan J. Shoulder impingement syndrome: a systematic review of clinical trial participant selection criteria. Shoulder Elbow. 2017 Jan;9(1):31-41. doi: 10.1177/1758573216663201. Epub 2016 Aug 20.
Background: PubMed 22581193Maenhout AG, Mahieu NN, De Muynck M, De Wilde LF, Cools AM. Does adding heavy load eccentric training to rehabilitation of patients with unilateral subacromial impingement result in better outcome? A randomized, clinical trial. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1158-67. doi: 10.1007/s00167-012-2012-8. Epub 2012 May 12.
Results publication: PubMed 15862727Luime JJ, Koes BW, Miedem HS, Verhaar JA, Burdorf A. High incidence and recurrence of shoulder and neck pain in nursing home employees was demonstrated during a 2-year follow-up. J Clin Epidemiol. 2005 Apr;58(4):407-13. doi: 10.1016/j.jclinepi.2004.01.022.
Results publication: PubMed 27083390Lewis J. Rotator cuff related shoulder pain: Assessment, management and uncertainties. Man Ther. 2016 Jun;23:57-68. doi: 10.1016/j.math.2016.03.009. Epub 2016 Mar 26.
Results publication: PubMed 25715230Littlewood C, Malliaras P, Chance-Larsen K. Therapeutic exercise for rotator cuff tendinopathy: a systematic review of contextual factors and prescription parameters. Int J Rehabil Res. 2015 Jun;38(2):95-106. doi: 10.1097/MRR.0000000000000113.
Results publication: PubMed 22507359Littlewood C, Ashton J, Chance-Larsen K, May S, Sturrock B. Exercise for rotator cuff tendinopathy: a systematic review. Physiotherapy. 2012 Jun;98(2):101-9. doi: 10.1016/j.physio.2011.08.002. Epub 2011 Oct 5.
Results publication: PubMed 28596288Smith BE, Hendrick P, Smith TO, Bateman M, Moffatt F, Rathleff MS, Selfe J, Logan P. Should exercises be painful in the management of chronic musculoskeletal pain? A systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(23):1679-1687. doi: 10.1136/bjsports-2016-097383. Epub 2017 Jun 8.
Results publication: PubMed 22349588Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
Results publication: PubMed 26160149Littlewood C, Bateman M, Brown K, Bury J, Mawson S, May S, Walters SJ. A self-managed single exercise programme versus usual physiotherapy treatment for rotator cuff tendinopathy: a randomised controlled trial (the SELF study). Clin Rehabil. 2016 Jul;30(7):686-96. doi: 10.1177/0269215515593784. Epub 2015 Jul 9.
Results publication: PubMed 26889612Coombes BK, Wiebusch M, Heales L, Stephenson A, Vicenzino B. Isometric Exercise Above but not Below an Individual's Pain Threshold Influences Pain Perception in People With Lateral Epicondylalgia. Clin J Pain. 2016 Dec;32(12):1069-1075. doi: 10.1097/AJP.0000000000000365.
Results publication: PubMed 23141188Naugle KM, Fillingim RB, Riley JL 3rd. A meta-analytic review of the hypoalgesic effects of exercise. J Pain. 2012 Dec;13(12):1139-50. doi: 10.1016/j.jpain.2012.09.006. Epub 2012 Nov 8.
Individual participant dataSharing planned: No

Related trials for Rotator Cuff Tendinitis

Recruiting
Ultrasound-Guided Extracorporeal Shock Wave Therapy for Calcific Tendinitis
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Recruiting
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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.

Mercè Balasch i Bernat, PhD principal investigator

Universitat de València

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Supra-threshold isometric exercise and Infra-threshold isometric exercise in people with Rotator Cuff Tendinitis, run by University of Valencia at 2 sites 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 4 inclusion and 3 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Pain intensity (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT03675399, which also lists 14 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 30 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.