UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000061723
Receipt number	R000066484
Scientific Title	short-term clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder: a non-randomised comparative study
Date of disclosure of the study information	2026/05/29
Last modified on	2026/07/23 18:34:58

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Basic information

Public title

short-term clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder

Acronym

clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder

Scientific Title

short-term clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder: a non-randomised comparative study

Scientific Title:Acronym

Comparison of clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder

Region

Japan

Condition

frozen shoulder

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

This study compares the treatment effects of manipulation under carvical nerve root block or conservative therapy for frozen shoulder, using a common rehabiritation protocol based on an algorithm tailored to the condition

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Disabilities of the Arm, Shoulder and Hand score after 2months

Key secondary outcomes

American shoulder and elbow surgeons score, shoulder pain and disability index,shoulder range of motion, inferior glemohumeral capsule thickness

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

In the manipulation group, manipulation under ultrasound-guided cervical nerve root brock is performed, followed by rehabilitation therapy. intra-articular injections or ultarasound-guided hydrorelease are additionally performed when clinically indicated according to pain severity and range of motion limitation.

Interventions/Control_2

In the conservative treatment group, patients underwent rehabilitation therapy. intra-articular injections or ultarasound-guided hydrorelease are additionally performed when clinically indicated according to pain severity and range of motion limitation.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Case with two or more directions of restricted range of motion in the shoulder(flexion<120 degree, abduction<120 degree, external rotation<30 degree, internal rotation<L5)
2)Case with shoulder pain lasting for at least one month

Key exclusion criteria

Patient with rotator cuff tears requiring surgery, calcific tendinitis, osteoarthritis of shoulder, and post surgical and post traumatic shoulder condition

Target sample size

Research contact person

Name of lead principal investigator

1st name Shintarou

Middle name

Last name Kudo

Organization

Morinomiya university of medical sience

Division name

Inclusive Medical Sciences Research Institute

Zip code

559-8611

Address

1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka

TEL

0666166911

Email

kudo@morinomiya-u.ac.jp

Public contact

Name of contact person

1st name Shun

Middle name

Last name okada

Organization

Morinomiya University of Medical Sciences

Division name

research support center

Zip code

559-8611

Address

1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka

TEL

0666166911

Homepage URL

Email

kenkyu@morinomiya-u.ac.jp

Sponsor or person

Institute

Morinomiya University of Medical Sciences

Institute

Department

Personal name

Shintarou Kudo

Funding Source

Organization

Morinomiya University of Medical Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Morinomiya University of Medical Sciences

Address

1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka

Tel

0666166911

Email

kudo@morinomiya-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

大阪府

Institutions

Other administrative information

Date of disclosure of the study information

2026 Year 05 Month 29 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Thirty participants were enrolled (15 conservative treatment, 15 MUC). At 2 months, baseline-adjusted between-group differences (MUC minus conservative) favored MUC for DASH (-20.0; 95% CI -29.5 to -10.4), ASES (33.2; 23.8 to 42.6), SPADI (-36.2; -47.9 to -24.4), and all passive ROM measures. The inferior glenohumeral capsule thickness did not differ between groups. No MUC-related adverse events were observed.

Results date posted

2026 Year 07 Month 23 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Thirty participants were enrolled: 15 in the conservative treatment group and 15 in the MUC group (11 men and 19 women overall). Continuous variables are mean standard deviation.
Age, years: conservative 55.4+/-7.3; MUC 54.7+/-10.3
Height, cm: 160.8+/-7.2; 162.3+/-10.5
Weight, kg: 60.0+/-11.9; 62.4+/-13.6
Forward flexion, degrees:105.0 +/- 20.2; 96.7+/-12.5
Abduction, degrees: 80.0+/-20.9; 78.7+/-16.7
External rotation, degrees: 24.0+/-9.5; 14.0+/-10.7
Internal rotation, cm: 43.5+/-9.0; 52.7+/-3.8
IGC thickness, mm: 3.0+/-1.2; 3.2+/-0.7
DASH score: 33.3+/-12.6; 50.6+/-24.1
ASES score: 37.3+/-13.7; 29.6+/-11.4
SPADI score: 68.7+/-15.3; 64.8+/-16.9

Participant flow

Thirty patients with frozen shoulder were enrolled: 15 in the conservative treatment group and 15 in the MUC group. At 1 month, assessments were completed by 15 and 14 participants, respectively. At 2 months, assessments were completed by 13 and 14 participants, respectively. In the conservative treatment group, one participant was hospitalized for another disease and one received MUC during follow-up; both missed the 2-month assessment. In the MUC group, one participant was lost to follow-up and missed both the 1- and 2-month assessments. Missing data were not imputed, and all available data were included in the linear mixed-model analyses.

Adverse events

No MUC-related fracture, dislocation, neurological complication, or vasovagal reaction was observed.

Outcome measures

Primary outcome
DASH score at 2 months: adjusted mean 27.5 in the conservative treatment group and 7.5 in the MUC group; difference (MUC minus conservative) -20.0 (95% CI -29.5 to -10.4), p<0.001

Secondary outcomes at 2 months
ASES score: 55.3 versus 88.5; difference 33.2 (95% CI 23.8 to 42.6), p<0.001
SPADI score: 48.2 versus 12.0; difference -36.2 (95% CI -47.9 to -24.4), p<0.001
Shoulder range of motion
forward flexion: 124.4 versus 169.6 degrees; difference 45.2 degrees (95% CI 37.0 to 53.3), p<0.001
abduction: 105.2 versus 165.6 degrees; difference 60.4 degrees (95% CI 49.1 to 71.7), p<0.001
external rotation: 39.3 versus 53.4 degrees; difference 14.1 degrees (95% CI 7.1 to 21.0), p=0.002
internal rotation (distance from the C7 spinous process to the tip of the thumb; lower values indicate better motion): 41.9 versus 23.6 cm; difference -18.3 cm (95% CI -22.5 to -14.1), p<0.001
IGC thickness: 2.7 versus 2.6 mm; difference -0.1 mm (95% CI -0.5 to 0.3), p=1.000

Plan to share IPD

yes

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2025 Year 06 Month 13 Day

Date of IRB

2025 Year 06 Month 13 Day

Anticipated trial start date

2025 Year 06 Month 15 Day

Last follow-up date

2025 Year 10 Month 31 Day

Date of closure to data entry

2025 Year 11 Month 09 Day

Date trial data considered complete

2025 Year 11 Month 09 Day

Date analysis concluded

2026 Year 05 Month 17 Day

Other

Other related information

Management information

Registered date

2026 Year 05 Month 28 Day

Last modified on

2026 Year 07 Month 23 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066484