Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial.

Background: Progressive high-load exercise (PHLE) has led to positive clinical results in patients with patellar and Achilles tendinopathy. However, its effects on rotator cuff tendinopathy still need to be investigated.
Purpose: To assess the clinical effects of PHLE versus low-load exercise (LLE) among patients with rotator cuff tendinopathy.
Study Design: Randomized controlled trial; Level of evidence, 1.
Methods: Patients with rotator cuff tendinopathy were recruited and randomized to 12 weeks of PHLE or LLE, stratified for concomitant administration of corticosteroid injection. The primary outcome measure was change from baseline to 12 weeks in the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, assessed in the intention-to-treat population.
Results: A total of 100 patients were randomized to PHLE (n = 49) or LLE (n = 51). Mean changes in the DASH questionnaire were 7.11 points (95% CI, 3.07-11.16) and 8.39 points (95% CI, 4.35-12.44) in the PHLE and LLE groups, respectively; this corresponded to a statistically nonsignificant adjusted mean group difference of -1.37 points (95% CI, -6.72 to 3.99; P = .61). Similar nonsignificant results were seen for pain, range of motion, and strength. However, a significant interaction effect was found between the 2 groups and concomitant corticosteroid use ( P = .028), with the largest positive change in DASH in favor of PHLE for the group receiving concomitant corticosteroid.
Conclusion: The study results showed no superior benefit from PHLE over traditional LLE among patients with rotator cuff tendinopathy. Further investigation of the possible interaction between exercise type and corticosteroid injection is needed to establish optimal and potentially synergistic combinations of these 2 factors.
Registration: NCT01984203 (ClinicalTrials.gov identifier): Rotator Cuff Tendinopathy Exercise Trial (RoCTEx).
Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: R.C. is a paid consultant for AbbVie, Amgen, Axellus A/S, Bristol-Meyers Squibb, Cambridge Weight Plan, Celgene, Eli Lilly, Hospira, MSD, Norpharma, Novartis, Orkla Health, Pfizer, Roche, Sobi, and Takeda; has received grants from Axellus A/S, AbbVie, Cambridge Weight Plan, Janssen, MSD, Mundipharma, Novartis, and Roche; has received payment for lectures from Abbott, Amgen, Axellus, Bayer HealthCare Pharmaceuticals, Biogen Idec, Bristol-Meyers Squibb, Cambridge Weight Plan, Ipsen, Janssen, Laboratoires Expanscience, MSD, Mundipharma, Norpharma, Novartis, Pfizer, Roche, Rottapharm-Madaus, Sobi, and Wyeth; has received grants for manuscript preparation from Axellus, Bristol-Meyers Squibb, Cambridge Weight Plan, and Aleris-Hamlet (via Norpharma); has received payment for development of educational presentations from Bristol-Meyers Squibb, MSD, and Pfizer; and received reimbursement for travel/accommodations/meeting expenses from Abbott, AbbVie, Axellus, Bristol-Myers Squibb, Cambridge Weight Plan, Celgene, Laboratoires Expanscience, Norpharma, Novartis, Pfizer, Roche, Rottapharm-Madaus, and Wyeth. This work was supported by the Region of Southern Denmark’s Research Fund, the Danish Rheumatism Association, the Ryholts Foundation, and the Danish Physiotherapy Association Foundation for Advancement of Research, Education, and Information. K.G.I. was funded by 1-year fellowships from Hospital Lillebaelt–Vejle Hospital, University of Southern Denmark, and Region of Southern Denmark. The Musculoskeletal Statistics Unit at the Parker Institute (R.C.) is supported by grants from the Oak Foundation.