Protocol summary

Study aim
Peppering vs. Single PRP Injection for Pain and Function in Lateral Epicondylitis"
Design
A double-blind randomized clinical trial on 34 patients with wrist injury, comparing the effects of PRP injection using Peppering and Single techniques alongside standard treatments on symptom relief and wrist function
Settings and conduct
Study location: Sports Medicine Department, Sina Hospital 3–4 mL of PRP was prepared from brachial artery blood by single-spin centrifugation. Patients were seated, elbow at 90°, forearm in pronation. 2 mL of 2% lidocaine was injected subcutaneously. Peppering: PRP injected in multiple directions at the point of maximal tenderness. Single: PRP injected only at the point of maximal tenderness. Patients were observed for 30 min, advised 48-hour rest, acetaminophen as needed, and no anti-inflammatories for 2 weeks. Outcomes (NRS, PRTEE, pressure pain threshold, hand grip) were measured at baseline, 4 and 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion: Age 18–60, lateral elbow tendinopathy, pain ≥2/10 NRS. Exclusion: Upper limb/neck surgery/injury, recent whiplash/fibromyalgia/cervical stenosis, chronic inflammatory/neuro-psychiatric disease, recent physio/acupuncture/chiropractic, nerve compression, bleeding disorder/NSAID/steroid use, pregnancy
Intervention groups
Group 1: PRP via Peppering + Counterforce brace + wrist extensor stretching Group 2: PRP via Single + Counterforce brace + wrist extensor stretching
Main outcome variables
Determining the effect of PRP injection by Peppering method versus single in the lateral epicondyle on pain symptoms and function in patients with acute elbow extensor tendinopathy./ Determining the effect of PRP injection by Peppering method versus single on wrist strength/NRS scale for lateral elbow pain/Function by Patient Related Tennis Elbow Evaluation or PRTEE/Pain pressure threshold

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251027067789N1
Registration date: 2025-12-13, 1404/09/22
Registration timing: prospective

Last update: 2025-12-13, 1404/09/22
Update count: 0
Registration date
2025-12-13, 1404/09/22
Registrant information
Name
Bahareh Golestani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3454 1905
Email address
golestani_b@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-12-22, 1404/10/01
Expected recruitment end date
2026-11-22, 1405/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the difference in the effect of platelet-rich plasma (PRP) injection using the Peppering ands single injection techniques on pain and function in patients with elbow extensor tendinopathy: A randomized, double-blind clinical trial
Public title
Evaluation of the difference in the effect of platelet-rich plasma (PRP) injection using the Peppering ands single injection techniques on pain and function in patients with elbow extensor tendinopathy: A randomized, double-blind clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain or tenderness to touch over the lateral epicondylitis and the insertion site of the extensor tendons Pain with gripping a hand dynamometer The pain may be aggravated by stretching or contracting the wrist extensors. At least a score of 2 on the NRS scale from 0 to 10.
Exclusion criteria:
Have a history of surgery on the upper limb. Have had surgery related to the cervical spine. Have a history of elbow dislocation or elbow fracture or tendon rupture Have a history of whiplash injury within the past 6 weeks. Have a history of fibromyalgia Have a history of cervical canal stenosis History of chronic inflammatory disease such as: lupus - rheumatoid arthritis - psoriasis Failure to participate in physical therapy, acupuncture, or chiropractic in the past 3 months Having symptoms of nerve compression, such as weakness of upper limb muscles, decreased deep reflexes in the upper limb, and decreased sensation Central nervous system involvement, such as MS Neurological _ Psychiatric or cognitive disorders and pregnancy The presence of any contraindications for physical therapy, such as skin wounds, infections, and malignancies Absence of a bleeding disorder No use of NSAIDs, steroids, or aspirin within the previous week
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
The distribution of volunteers will be done by random block design with variable blocks of two, four or six (one group with the symbol A and the other group with the symbol B) and using the random number table of the Random allocation software. The sample allocation ratio will be 1:1 and volunteers will be randomly assigned to one of the two injection groups, Single and Peppering.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was conducted as a randomized, double-blind clinical trial. Both participants and outcome assessors were blinded to the type of intervention. To maintain blinding, all injections were performed behind a sterile drape and out of the patient’s visual field, using identical syringes, equipment, and a uniform local anesthesia protocol in both groups. The duration of the procedure was also standardized to avoid any perceptible differences between the two injection techniques. All injections were performed by a single physician who, due to the inherent differences between the Peppering and Single techniques, was aware of the allocation but had no role in patient assessment or data collection. Outcome measures, including the Numerical Rating Scale (NRS), the Patient-Rated Tennis Elbow Evaluation (PRTEE), grip strength, and Pain Pressure Threshold (PTT), were recorded by an independent assessor blinded to group assignment. Participants were randomized into two groups in a 1:1 ratio using sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The success of blinding was evaluated during follow-up by directly asking both participants and assessors to guess the assigned group. Unblinding was allowed only in cases of medical necessity and was fully documented.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sina Hospital - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Sina Hospital, Hasanabad Square, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2025-05-25, 1404/03/04
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1404.026

Health conditions studied

1

Description of health condition studied
Lateral elbow extensor tendinopathy
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
Pain intensity
Timepoint
It is being evaluated 4 and 8 weeks after injection.
Method of measurement
Pain intensity will be assessed using the Numerical Rating Scale (NRS), which ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the worst possible pain."

2

Description
Grip strength
Timepoint
It is being evaluated 4 and 8 weeks after injection.
Method of measurement
Grip strength will be measured using a hand-held dynamometer, which quantifies the maximum force exerted by the participant's grip.

3

Description
The Pressure Pain Threshold
Timepoint
It is being evaluated 4 and 8 weeks after injection.
Method of measurement
The Pressure Pain Threshold (PPT) will be measured using an algometer, a device that applies gradual pressure to a specific point on the body. The participant will report when the pressure becomes painful.

4

Description
The Patient-Rated Tennis Elbow (PRTE) questionnaire
Timepoint
It is being evaluated 4 and 8 weeks after injection.
Method of measurement
The Patient-Rated Tennis Elbow (PRTE) questionnaire evaluates the severity of symptoms and functional limitations caused by tennis elbow. It uses a Likert scale (0-10) for scoring, where 0 means "no pain" or "no difficulty," and 10 represents "worst possible pain" or "unable to perform the activity. Its subscales include 1. Pain Subscale : Measures pain intensity during rest and specific activities. 2. Function Subscale: Assesses limitations in daily activities and work tasks. 3. Impact on Quality of Life

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Injection of platelet-rich plasma (PRP) produced by a kit manufactured by Celltech Biogen using the peppering method along with conventional treatments including Counterforce brace and wrist extensor stretching exercises
Category
Treatment - Other

2

Description
Second Intervention group: Injection of platelet-rich plasma (PRP) produced by a kit manufactured by Celltech Biogen Company using a single injection method along with conventional treatments including Counterforce brace and wrist extensor stretching exercises.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Bahareh Golestani
Street address
Sina Hospital, Hasanabad Square, Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8587
Email
hosp_sina@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Vice Chancellor for Research and Technology, 6th Floor, Central Building of Tehran University of Medical Sciences, Ghods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahareh Golestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sina Hospital, Hasanabad Square, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
5395514176
Phone
+98 21 6491 0700
Email
golestani_b@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Abolhasani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Sina Hospital, Hasanabad Square, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
5395514176
Phone
+98 21 6491 0700
Email
maryam.abolhasani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahareh Golestani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sina Hospital, Hasanabad Square, Imam Khomeini street
City
Tehran
Province
Tehran
Postal code
5395514176
Phone
+98 21 6491 0700
Email
golestani_b@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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