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

NCT03675399 | Completed

• 1 other identifier: H1528701290644
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rotator Cuff Tendinitis

Keywords

isometric exercise; rotator cuff; pain threshold

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  45 minutes post-intervention

Secondary Outcomes (12)

• Pressure Pain Thresholds (PPT)

  Baseline, immediately post-intervention and 45 minutes post-intervention

• Pressure Pain Thresholds (PPT)

  Immediately post-intervention

• Pressure Pain Thresholds (PPT)

  45 minutes post-intervention

• Conditioned pain modulation (CPM)

  Baseline

• Conditioned pain modulation (CPM)

  Immediately post-intervention

Study Arms (3)

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.

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.

Other: Infra-threshold isometric exercise

Control

NO INTERVENTION

Participants will remain resting.

Interventions

Supra-threshold isometric exercise OTHER

The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).

Supra-threshold isometric exercise

Infra-threshold isometric exercise OTHER

The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).

Infra-threshold isometric exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Mercè Balasch i Bernat

Valencia, Valencia, 46021, Spain

Location

Mercè Balasch i Bernat

Valencia, 46021, Spain

Location

Related Publications (14)

• 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.

  PMID: 15163107 BACKGROUND

• 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.

  PMID: 28572848 BACKGROUND

• 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.

  PMID: 22581193 BACKGROUND

• 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.

  PMID: 15862727 RESULT

• 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.

  PMID: 27083390 RESULT

• 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.

  PMID: 25715230 RESULT

• 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.

  PMID: 22507359 RESULT

• 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.

  PMID: 28596288 RESULT

• 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.

  PMID: 22349588 RESULT

• 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.

  PMID: 26160149 RESULT

• 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.

  PMID: 26889612 RESULT

• 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.

  PMID: 23141188 RESULT

• 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.

  PMID: 25979840 RESULT

• 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.

  PMID: 33887445 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Mercè Balasch i Bernat, PhD

  Universitat de València

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Exercise sessions were delivered by a physiotherapist who was not involved in the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Professor

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 18, 2018
• Study Start: June 1, 2019
• Primary Completion: October 15, 2020
• Study Completion: April 15, 2021
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)