Trial Outcomes & Findings for Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis (NCT NCT03479502)

Results Overview

The American Shoulder and Elbow Score questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. ASES results are in the 0 to 100 range, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the lower the score, the greater the level of shoulder disability. Transforming the pain and the ADLs domains into the final score relies on the following formulas: Pain = 5 x (10 - Score from question 7)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2024-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Methylprednisolone Patients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) with 20 patients in each group. Injections will be administered by the treating physician. Methylprednisolone Injectable Product: 3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks	Doxycycline Patients meeting the inclusion criteria will be randomized or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. Doxycycline Injection: 3 intra-articular injections of Doxycycline Injection spaced every two weeks
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intra-articular Doxycycline: A Novel Treatment of Adhesive Capsulitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Methylprednisolone n=1 Participants Patients meeting the inclusion criteria will be randomized into either the control group of intra-articular injection of 40mg Methylprednisolone once every 2 two weeks for 4 weeks (day 1, week 2, week 4) with 20 patients in each group. Injections will be administered by the treating physician. Methylprednisolone Injectable Product: 3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks	Doxycycline Patients meeting the inclusion criteria will be randomized or the experimental group of intraarticular injection of 50 mg doxycycline once every 2 two weeks for 4 weeks (day 1, week 2, week 4), with 20 patients in each group. Injections will be administered by the treating physician. Doxycycline Injection: 3 intra-articular injections of Doxycycline Injection spaced every two weeks	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants	—	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: 0 participants were analyzed due to the risk of de-identification with only 1 person enrolled.

The American Shoulder and Elbow Score questionnaire was developed to provide a standardized method for evaluating shoulder function and has been validated in patients with any array of shoulder pathologies. ASES results are in the 0 to 100 range, where 0 indicates a worse shoulder condition and 100 indicates best shoulder condition, so the lower the score, the greater the level of shoulder disability. Transforming the pain and the ADLs domains into the final score relies on the following formulas: Pain = 5 x (10 - Score from question 7)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: 0 participants were analyzed due to the risk of de identification with only 1 person enrolled.

The ROM measurements will include forward flexion, abduction, external rotation at the side and at 90 degrees abduction, and internal rotation at the side and at 90 degrees abduction recorded by the treating physician at follow up visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: 0 parrticipants were ananlyzed due to the risk of de identification with only person enrolled.

number of medical co-morbidities per participant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: 0 participants enrolled due to the risk of de identification with only 1 person enrolled.

Length of time participants have experienced shoulder symptoms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: 0 participants enrolled due to the risk of de identifying with only 1 person enrolled.

Number of participants with current dominant symptom and/or dominant symptom with disease onset

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: 0 participants enrolled due to the risk of de identifying with only 1 person enrolled.

Number of patients that have pain while sitting or have ever had pain while sitting will be recorded using patient-reported survey and review of the patient's electronic medical record in Epic.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: 0 participants enrolled due to the risk of de identifying with only 1 person enrolled

Number of participants with current dominant symptom and/or dominant symptom with disease onset

Outcome measures

Outcome data not reported

Adverse Events

Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Doxycycline

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

Rosemary Sanders, Research Coordinator

Vanderbilt_University MC

Phone: 16155930171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place