Trial Outcomes & Findings for Exercise Into Pain in Chronic Rotator Cuff Related Shoulder Pain: a Prospective Single-Group Feasibility Study (NCT NCT04154345)

Results Overview

It is analysed in terms of attendance to the physiotherapist-led sessions. Good level of adherence is defined by attendance of 7/9 (78%) of physiotherapist led-sessions

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

measurement every session, final measure at the end of 12 weeks

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Painful Exercises The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Overall Study STARTED	12
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Painful Exercises The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Overall Study Covid-19 pandemic	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Painful Exercises n=12 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Age, Continuous	50.5 years n=12 Participants
Sex: Female, Male Female	7 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=12 Participants
Body Mass Index	23.2 kg/m^2 n=12 Participants
duration of symptoms	6.5 months n=12 Participants
dominant side affected	7 Participants n=12 Participants
previous treatment	8 Participants n=12 Participants

PRIMARY outcome

Timeframe: measurement every session, final measure at the end of 12 weeks

It is analysed in terms of attendance to the physiotherapist-led sessions. Good level of adherence is defined by attendance of 7/9 (78%) of physiotherapist led-sessions

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Rate of Adherence (Physiotherapy Session)	7 Participants

PRIMARY outcome

Timeframe: measurement every home exercise session, final measure at the end of 12 weeks

It is analysed in terms of adherence to home exercises. Good level of adherence is achieved when patients completed at least 22 of 27 (81%) sessions. One session of non-supervised (home) exercise was considered completed when at least 80% of the total amount of sets and repetitions were executed as prescribed by the physiotherapist.

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Rate of Adherence (Adherence Home Exercises)	4 Participants

PRIMARY outcome

Timeframe: value at baseline minus value at 12 weeks

There are 13 items, divided in two subscales: pain (5 items) and function (8 items). Each item is scored from 0 (no pain/no difficulty) to 10 (worst imaginable pain/so difficult it requires help) on a NPRS. The final score is a percentage derived from an average of the two subscales, where higher score means worse outcome.

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Shoulder Pain and Disability Index (SPADI)	29.3 score on a scale Interval 13.8 to 75.9

SECONDARY outcome

Timeframe: value at baseline minus value at 12 weeks

Fear-Avoidance Beliefs Questionnaire, Subscale Physical Activity (range: 0-24) Higher scores indicate higher fear-avoidance beliefs

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Fear-Avoidance Beliefs Questionnaire (FABQ-PA)	1.5 score on a scale Interval -3.0 to 18.0

SECONDARY outcome

Timeframe: value at baseline minus value at 12 weeks

Fear-Avoidance Beliefs Questionnaire, Subscale Work (range: 0-42) Higher scores indicate higher fear-avoidance beliefs

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Fear-Avoidance Beliefs Questionnaire (FABQ-W)	3 score on a scale Interval -18.0 to 16.0

SECONDARY outcome

Timeframe: value at baseline minus value at 12 weeks

It is a shortened version of the Fear of Pain Questionnaire-III. The total score ranges between 9 and 45. Higher scores indicate more fear and anxiety associated with pain.

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Fear of Pain Questionnaire (FPQ-9)	0 score on a scale Interval -6.0 to 17.0

SECONDARY outcome

Timeframe: value at 12 weeks minus baseline

Population: Data on passive ROM in external rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Passive Range of Motion (ROM) in External Rotation	4 degrees Interval -21.0 to 22.0

SECONDARY outcome

Timeframe: value at 12 weeks minus baseline

Population: Data on passive ROM in internal rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Passive ROM in Internal Rotation	1 degrees Interval -21.0 to 22.0

SECONDARY outcome

Timeframe: value at 12 weeks minus baseline

Population: Data on passive ROM in scaption were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Passive ROM in Scaption	27 degrees Interval 11.0 to 49.0

SECONDARY outcome

Timeframe: value at 12 weeks minus baseline

Population: Data on active ROM in external rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Active ROM in External Rotation	6 degrees Interval -32.0 to 22.0

SECONDARY outcome

Timeframe: value at 12 weeks minus baseline

Population: Data on active ROM in internal rotation were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Active ROM in Internal Rotation	-4 degrees Interval -38.0 to 8.0

SECONDARY outcome

Timeframe: value at 12 weeks minus baseline

Population: Data on active ROM in scaption were lost for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the inclinometer. The unit of measure is degrees. Higher values indicate higher ROM.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Active ROM in Scaption	24 degrees Interval 7.0 to 43.0

SECONDARY outcome

Timeframe: value at 12 weeks minus value at baseline

Population: Data on MVC in external rotation were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is not possible to present change between baseline and 12 weeks for 6 patients.

It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Maximum Voluntary Contraction (MVC) in External Rotation	14.55 Newtons Interval -44.79 to 30.4

SECONDARY outcome

Timeframe: values at 12 weeks minus values at baseline

Population: Data on MVC in internal rotation were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is not possible to present change between baseline and 12 weeks for 6 patients.

It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
MVC in Internal Rotation	26.64 Newtons Interval -25.5 to 34.98

SECONDARY outcome

Timeframe: values at 12 weeks minus baseline

Population: Data on MVC in scaption were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients), while one value was lost because of an error during the measurement process. Therefore, it is possible to present change between baseline and 12 weeks only for 5 patients.

It is measured with the hand-held dynamometer. The unit of measure is Newtons. Higher values indicate greater strength.

Outcome measures

Outcome measures
Measure	Painful Exercises n=5 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
MVC in Scaption	6.54 Newtons Interval -40.54 to 30.07

OTHER_PRE_SPECIFIED outcome

Timeframe: value at baseline minus value at 12 weeks

Population: Data on ultrasonographic measures were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the Ultrasound machine at rest and at 60 degrees of elevation in the scapular plane. (in millimeters)

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Acromiohumeral Distance (AHD)	0.00 millimeters Interval -1.48 to 1.13

OTHER_PRE_SPECIFIED outcome

Timeframe: value at baseline minus value at 12 weeks

Population: Data on ultrasonographic measures were not collected at 12 weeks for 6 out of 12 patients because of reasons related to COVID-19 (restrictions and/or illness of the patients). Therefore, it is possible to present change between baseline and 12 weeks only for 6 patients.

It is measured with the Ultrasound machine in the Crass position (in millimeters)

Outcome measures

Outcome measures
Measure	Painful Exercises n=6 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Supraspinatus Tendon Thickness (STT)	-0.17 millimeters Interval -0.95 to 0.72

OTHER_PRE_SPECIFIED outcome

Timeframe: value at baseline minus value at 12 weeks

The Global Perceived Effect (GPE) of recovery was measured after 1 week of treatment, at 6 week and at 12 weeks with the question: "To what extent do you feel recovered compared to the beginning of the treatment?" (from 1=very much better to 7=very much worse). Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Global Perceived Effect - Recovery (GPE-R)	3 score on a scale Interval -1.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: value at baseline minus value at 12 weeks

The Global Perceived Effect (GPE) of satisfaction was measured after 1 week of treatment, at 6 week and at 12 weeks with the question "To what extend are you satisfied about your treatment?" (from 1=absolutely satisfied to 7=absolutely dissatisfied). Higher scores indicate worse outcome.

Outcome measures

Outcome measures
Measure	Painful Exercises n=8 Participants The pain allowed during exercises ranges between 4 and 7 on NPRS (Numeric Pain Rating Scale) Exercise therapy (exercising into pain): The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS for 9 weeks, then pain ratings are 0-2 for the remaining 3 weeks. Every physiotherapy session includes also 15 minutes of manual therapy.
Global Perceived Effect - Satisfaction (GPE-S)	1 score on a scale Interval -1.0 to 1.0

Adverse Events

Painful Exercises

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Filip Struyf

University of Antwerp

Phone: 32652783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place