The Effectiveness of Isometric Exercise on the Management of Chronic Shoulder Pain

Chronic Shoulder Pain Clinical Trial

Official title:

The Influence of the Intensity of Isometric Exercise on Pain Intensity, Muscle Pain Sensitivity and Function in Patients With Chronic Shoulder Pain: A Parallel Single-blind Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475965
• Other study ID #: EIH UCM
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: October 5, 2019

Study information

• Verified date: July 2020
• Source: Universidad Católica del Maule
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate the influence of the intensity of Isometric Contraction of shoulder external rotators, comparing the effect of a high-level IC (80% maximal voluntary isometric contraction) versus a low-level Isometric Contraction (20% maximal voluntary isometric contraction) on pain intensity, pain thresholds, and function in chronic pain shoulder patients.

Description:

This was a single-blinded, randomized parallel study. Eighty-two patients presenting chronic musculoskeletal shoulder pain were allocated to two groups. Patients in group 1 (n= 41) received a five-series Isometric Contraction of shoulder external rotators at 20% maximal voluntary isometric contraction, while patients in group 2 (n= 41) received similar protocol but the intensity of contraction was set at 80% maximal voluntary isometric contraction. In both cases, each series of IC was done until exhaustion or up to a maximum of 5 minutes. Patients received five sessions of treatment during a two-week period. Outcome measures included muscle pain sensitivity (pressure pain thresholds) and pain intensity (pain intensity numerical rating score), and shoulder function (Constant Score).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 5, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female having a chronic shoulder soft-tissue injury of at least 3 month duration resulting in a mild to moderate level of disability (Constant score scale), pain intensity score between 3 and 8 points (pain intensity numerical rating scale), and age between 18 and 65 years.

Exclusion Criteria:

• Participants were excluded if they had any contraindications related to the application of isometric exercise, neurological problems (central or peripheral), concomitant physiotherapy or chiropractic treatment, fibromyalgia or general systemic disease conditions, had participated in any moderate or vigorous physical activity in the las 72 hours previous the outcome assessment.

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain

Intervention

Other:
• Isometric exercise for shoulder external rotators
The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).

Locations

Country	Name	City	State
Chile	Hospital Traumatológico	Concepción	Bio Bio

Sponsors (1)

Lead Sponsor	Collaborator
Jorge Fuentes

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity Numerical Rating Scale	The Pain intensity Numerical Rating Scale is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a number on a horizontally depicted 11-point scale from 0 (no pain) to 10 (worst possible pain). Based on its several advantages (i.e. more responsive, sensitive and easy to administer) over other pain measuring scales, the PI-NRS has been recommended as a core outcome measure in clinical trials of chronic pain treatments. The minimal clinically important change for this scale has been reported to range from 1.5 to 3.2 points. Other authors have determined a meaningful clinical change of 2 points from baseline pain scores.	Baseline through the end of the intervention (2 week period)
Secondary	Shoulder function	The shoulder function was assessed by the Constant Score scale. This is a multi-item functional scale assessing pain, activities of daily living, range of motion and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function respectively.; Pain and activities of daily living (subjective aspects receiving 35 points) are answered by the patient ; and range of motion and strength (objective aspects receiving 65 points) require a physical evaluation and are answered by the orthopaedic surgeon or the physiotherapist.	Baseline through the end of the intervention (2 week period)
Secondary	Muscle pain sensitivity	Muscle pain sensitivity was evaluated through the pressure pain threshold, or the minimum pressure that induces pain or discomfort. Pressure pain thresholds measurements have been shown to have good or excellent inter-rater intraclass correlation coeficient values ranging from 0.74 to 0.90, and intra-rater reliability interclass correlation coefficient values ranging from 0.75 to 0.99. The minimal clinically important change calculated for this outcome has been reported to be = 1.10 Kg/cm2/s	Baseline through the end of the intervention (2 week period)