UMIN-ICDS Clinical Trial

Public title

Effect of Trigger Point Injection in Patients with Post-Mastectomy Pain Syndrome: A Multicenter Prospective Observational Study.

Acronym

TIPS Study

Scientific Title

Effect of Trigger Point Injection in Patients with Post-Mastectomy Pain Syndrome: A Multicenter Prospective Observational Study.

Scientific Title:Acronym

TIPS Study

Region

Japan

Condition

Post-Mastectomy Pain Syndrome

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To exploratorily evaluate the effects of trigger point injection on pain intensity and shoulder function in patients with post-mastectomy pain syndrome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change in pain intensity measured using the numerical rating scale from baseline to 1 week after trigger point injection

Key secondary outcomes

1) Changes in pain intensity measured using the numerical rating scale from baseline to immediately and 2, 3, and 4 weeks after trigger point injection
2) Changes in shoulder range of motion (flexion and abduction) from before to immediately after trigger point injection
3) Change in shoulder function from baseline to 1 week after trigger point injection
4) Sites of trigger point injection
5) Adverse events after trigger point injection

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Patients with pathologically confirmed stage 0-3 breast cancer who have undergone curative surgery.
2) Patients who are under follow-up after curative surgery without evidence of recurrence or metastasis. Patients receiving endocrine therapy, anti-HER2 therapy, or abemaciclib are eligible.
3) Patients with pain in the chest, shoulder, or neck on the operated side that developed after surgery and has persisted for at least 6 months (post-mastectomy pain syndrome).
4) Patients receive trigger point injection for post-mastectomy pain syndrome.
5) Patients aged 18 years or older.

Key exclusion criteria

1) Patients with severe comorbidities.
2) Patients with severe psychiatric disorders.
3) Patients currently enrolled in a clinical trial or another clinical study that may affect the outcomes of this study.

Target sample size

15

Name of lead principal investigator

1st name	Naruaki
Middle name
Last name	Kawasaki

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Department of Palliative Therapy

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo, Japan

TEL

03-3520-0111

Email

naruaki.kawasaki@jfcr.or.jp

Name of contact person

1st name	Naruaki
Middle name
Last name	Kawasaki

Organization

Cancer Institute Hospital of Japanese Foundation for Cancer Research

Division name

Department of Palliative Therapy

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo, Japan

TEL

03-3520-0111

Homepage URL

Email

naruaki.kawasaki@jfcr.or.jp

Institute

Japanese Foundation for Cancer Research

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

National Cancer Center Hospital

Name of secondary funder(s)

Organization

Ethics Committee of Japanese Foundation for Cancer Research

Address

3-8-31 Ariake, Koto-ku, Tokyo

Tel

03-3520-0111

Email

med.shinsa@jfcr.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

09

Month

11

Day

Date of IRB

Anticipated trial start date

2026

Year

12

Month

01

Day

Last follow-up date

2027

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter prospective observational study of patients receiving trigger point injection as part of routine clinical care for post-mastectomy pain syndrome. Pain intensity will be prospectively assessed before, immediately after, and 1, 2, 3, and 4 weeks after trigger point injection. Shoulder range of motion before and immediately after the injection, shoulder function at 1 week, injection sites, adverse events, and history of previous trigger point injections will also be collected. The primary outcome is the change in pain intensity from before trigger point injection to 1 week after the injection.

Registered date

2026

Year

09

Month

12

Day

Last modified on

2026

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072009