Trial Outcomes & Findings for Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension? (NCT NCT00992927)

Last Updated: 2011-08-17

Results Overview

1. before intervention for all participants 2. using a goniometer 3. patient sitting on a stool with the arm at anatomical position 4. worst: 0 degree 5. best: 360 degree

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

1 month

Results posted on

2011-08-17

Participant Flow

Recruitment Dates: from Mar 2008 until Oct 2009 Type of Location: outpatient clinic at a university hospital Method of Recruitment: informed consent from eligible patients

Participants with other diagnoses than the painful stiff shoulder, such as full-thickness rotator cuff tear, osteoarthritis and others, were excluded from the trial when the final diagnosis was determined.

Participant milestones

Participant milestones
Measure	CPIHD Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.	CRIHD Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Overall Study STARTED	32	22
Overall Study COMPLETED	32	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPIHD n=32 Participants Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.	CRIHD n=22 Participants Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Age Continuous	61.09 years STANDARD_DEVIATION 10.621 • n=5 Participants	56.55 years STANDARD_DEVIATION 9.521 • n=7 Participants	59.24 years STANDARD_DEVIATION 10.343 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Korea, Republic of	32 participants n=5 Participants	22 participants n=7 Participants	54 participants n=5 Participants
Pain Measured by Visual Analogue Scale (VAS)	6.87 cm STANDARD_DEVIATION 3.01 • n=5 Participants	7.17 cm STANDARD_DEVIATION 2.09 • n=7 Participants	6.99 cm STANDARD_DEVIATION 2.65 • n=5 Participants
Range of Motion (ROM) of the Glenohumeral Joint	223.56 degree STANDARD_DEVIATION 42.111 • n=5 Participants	203.05 degree STANDARD_DEVIATION 46.163 • n=7 Participants	215.20 degree STANDARD_DEVIATION 44.555 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

1. before intervention for all participants 2. using a goniometer 3. patient sitting on a stool with the arm at anatomical position 4. worst: 0 degree 5. best: 360 degree

Outcome measures

Outcome measures
Measure	CPIHD n=32 Participants Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.	CRIHD n=22 Participants Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Range of Motion (ROM) of the Glenohumeral Joint	261.95 degree Standard Deviation 47.197	241.84 degree Standard Deviation 57.304

SECONDARY outcome

Timeframe: 1 month

1. before intervention for all participants 2. using 10cm horizontal visual analog scale 3. best: 0cm (no pain) 4. worst: 10cm (worst pain)

Outcome measures

Outcome measures
Measure	CPIHD n=32 Participants Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.	CRIHD n=22 Participants Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Pain Measured by Visual Analogue Scale (VAS)	2.96 cm Standard Deviation 2.89	5.03 cm Standard Deviation 2.95

Adverse Events

CPIHD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CRIHD

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

Sun Gun Chung/Professer

Seoul National University Hospital

Phone: +82-2-2072-3954

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place